To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT02853435

Collaborator

(none)

Enrollment

Locations

Arms

14.4

Actual Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is divided in 2 parts. Part 1a is being conducted to evaluate the safety, tolerability, and relative bioavailability of the 2 free base tablet formulations (roller compacted [RC] and high shear wet granulation [HSWG]) compared to the reference capsule formulation under fasted conditions. This is a 3-period; cross-over study that will guide which gepotidacin formulation will be used for future studies. Following review of pharmacokinetic (PK) and safety data in Part 1a, a decision will be made whether to proceed with Parts 1b and 2.

Part 1b is a 2-period, cross-over study and will assess the effect of food on the PK of the selected gepotidacin tablet formulation from Part 1a. In Part 2, the PK of the selected gepotidacin tablet formulation from Part 1a in Japanese (2a) and Chinese (2b) subjects will be evaluated under fasted conditions.

The duration of the study (from Screening to the Follow-up visit) will be approximately 44 days (Part 1a), 41 days (Part 1b) and 38 days (Part 2a and 2b each), respectively. The approximate number of subjects enrolled in Part 1a will be 27 (9 subjects in each of the 3 treatment sequences), 16 in Part 1b (8 subjects in each of the 2 treatment sequences) and 12 Japanese and 12 Chinese subjects in Part 2a and 2b, respectively.

Condition or Disease	Intervention/Treatment	Phase
Infections, Bacterial	Drug: Gepotidacin RC Tablet Drug: Gepotidacin HSWG Tablet Drug: Gepotidacin Capsule	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I; Multi-Center; Open-Label (Parts 1 and 2); Randomized, Double-Blind, Placebo-Controlled (Part 3); Single-Dose; 3-Part Study to Evaluate the Relative Bioavailability of Three Formulations in Healthy Subjects, Food Effect on Tablet Formulation in Healthy Subjects, and Pharmacokinetics of Gepotidacin (GSK2140944) in Japanese Subjects in Fasted and Fed States

Actual Study Start Date :

Aug 4, 2016

Actual Primary Completion Date :

Oct 17, 2017

Actual Study Completion Date :

Oct 17, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part1a: Gepotidacin 1500 mg-Sequence A-capsules, B-RC, C-HSWG Subjects will be receive treatment sequence (ABC) which is a single dose of gepotidacin 1500 mg (three tablets of 500 mg) reference capsule (Treatment A) in Period 1, 1500 mg (two tablets of 750 mg) RC tablet (Treatment B) in Period 2 or 1500 mg (two tablets of 750 mg) HSWG tablet (Treatment C) in Period 3, according to randomization. There will be a washout period of at least 3 days between doses.	Drug: Gepotidacin RC Tablet The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin HSWG Tablet The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin Capsule It is a pink gelatin size 00 capsule with no identifying markings containing slightly agglomerated pale yellow to grayish yellow to yellowish gray powder. This is an immediate release capsules containing gepotidacin 500 mg (mesylate salt) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing capsules.
Experimental: Part1a: Gepotidacin 1500 mg-Sequence C-HSWG, A-capsules, B-RC) Subjects will receive treatment sequence (CAB) to receive a single dose of gepotidacin 1500 mg (two tablets of 750 mg) HSWG tablet (Treatment C) in Period 1, 1500 mg (three tablets of 500 mg) reference capsule (Treatment A) in Period 2 or 1500 mg (two tablets of 750 mg) RC tablet (Treatment B) in Period 3 according to randomization. There will be a washout period of at least 3 days between doses.	Drug: Gepotidacin RC Tablet The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin HSWG Tablet The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin Capsule It is a pink gelatin size 00 capsule with no identifying markings containing slightly agglomerated pale yellow to grayish yellow to yellowish gray powder. This is an immediate release capsules containing gepotidacin 500 mg (mesylate salt) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing capsules.
Experimental: Part1a: Gepotidacin 1500 mg-Sequence B-RC, C-HSWG, A-capsules) Subjects will receive treatment sequence (BCA) to receive a single dose of gepotidacin 1500 mg (two tablets of 750 mg) RC tablet (Treatment B) in period 1, 1500 mg (two tablets of 750 mg) HSWG tablet (Treatment C) in Period 2, or 1500 mg (three tablets of 500 mg) (Treatment A) in Period 3 reference capsule according to randomization.. There will be a washout period of at least 3 days between doses.	Drug: Gepotidacin RC Tablet The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin HSWG Tablet The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin Capsule It is a pink gelatin size 00 capsule with no identifying markings containing slightly agglomerated pale yellow to grayish yellow to yellowish gray powder. This is an immediate release capsules containing gepotidacin 500 mg (mesylate salt) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing capsules.
Experimental: Part1b: Gepotidacin 1500 mg-Sequence DE-fasted followed by fed Subjects will receive treatment sequence (DE) according to randomization which is a single 1500 mg (two tablets of 750 mg) dose of gepotidacin tablet (RC or HSWG) selected from Part 1a under fasted condition (Treatment D) in Period 1 followed by fed conditions (Treatment E) in period 2. There will be a washout period of at least 3 days between doses.	Drug: Gepotidacin RC Tablet The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin HSWG Tablet The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets.
Experimental: Part1b: Gepotidacin 1500 mg-Sequence ED-fed followed by fasted Subjects will be receive treatment sequence (ED) according to randomization which is single 1500 mg (two tablets of 750 mg) dose of gepotidacin tablet (RC or HSWG) selected from Part 1a under fed condition (Treatment E) in period 1 followed by fasted conditions (Treatment D) in Period 2. There will be a washout period of at least 3 days between doses.	Drug: Gepotidacin RC Tablet The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin HSWG Tablet The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets.
Experimental: Part 2a: Gepotidacin 1500 mg (RC or HSWG)- Japanese subjects Japanese subjects will receive a single 1500 mg (two tablets of 750 mg) dose of gepotidacin tablet (RC or HSWG) selected from Part 1a.	Drug: Gepotidacin RC Tablet The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin HSWG Tablet The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets.
Experimental: Part 2b: Gepotidacin 1500 mg (RC or HSWG)- Chinese subjects Chinese subjects will receive a single 1500 mg (two tablets of 750 mg) dose of gepotidacin tablet (RC or HSWG) selected from Part 1a.	Drug: Gepotidacin RC Tablet The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin HSWG Tablet The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets.

Outcome Measures

Primary Outcome Measures

Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of Plasma Gepotidacin for Part 1a [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for pharmacokinetic (PK) analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 milliliters (mL) of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. The PK Parameter Population consisted of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. Statistics has been presented on geometric least square (LS) means.
Area Under the Concentration-time Curve (AUC) From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC [0-t]) of Plasma Gepotidacin for Part 1a [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Statistics has been presented on geometric LS means.
Relative Bioavailability of Drug (Frel) of Plasma Gepotidacin for Part 1a [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. NA indicates data was not available as this was the reference capsule the Frel of each tablet type was being compared to.
Maximum Observed Concentration (Cmax) Determined Directly From the Concentration Time Data of Plasma Gepotidacin for Part 1a [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Statistics has been presented on geometric LS means.
Time to First Occurrence of Cmax (Tmax) of Plasma Gepotidacin for Part 1a [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of Plasma Gepotidacin for Part 1a [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Terminal Phase Half-life (t1/2) of Plasma Gepotidacin for Part 1a [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Total Unchanged Drug (Total Amount of Drug Excreted in Urine [Ae Total]) for Part 1a [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours]
PK urine samples were collected at 0 (predose), 0 to 2, 2 ot 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher
Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Plasma Gepotidacin for Part 1a [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours]
PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Renal Clearance of Drug in Urine (CLr) for Part 1a [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours]
PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours]
PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Only those participants available at the specific time points were analyzed (represented by n = X in the category titles).
Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 12 Hours (AUC [0-12]) for Part 1a [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.]
PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher
Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 24 Hours (AUC [0-24]) After Dosing for Part 1a [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours]
PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher
Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 48 Hours (AUC [0-48]) After Dosing for Part 1a [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours]
PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Only those participants with data available at the indicated time point were analyzed.
AUC (0-infinity) of Plasma Gepotidacin for Part 1b [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
AUC (0-t) of Plasma Gepotidacin for Part 1b [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Cmax of Plasma Gepotidacin for Part 1b [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Tmax of Plasma Gepotidacin for Part 1b [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Tlag of Plasma Gepotidacin for Part 1b [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
t1/2 of Plasma Gepotidacin for Part 1b [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
AUC (0-infinity) of Plasma Gepotidacin for Part 2 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
AUC (0-t) of Plasma Gepotidacin for Part 2 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Cmax of Plasma Gepotidacin for Part 2 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Tlag of Plasma Gepotidacin for Part 2 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Tmax of Plasma Gepotidacin for Part 2 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
t1/2 of Plasma Gepotidacin for Part 2 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Total Unchanged Drug (Ae Total) for Part 2 [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.]
PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Ae (t1-t2) for Part 2 [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.]
PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
AUC (0-12) for Part 2 [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.]
PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
AUC (0-24) for Part 2 [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.]
PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
AUC (0-48) for Part 2 [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.]
PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
fe% for Part 2 [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.]
PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
CLr for Part 2 [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.]
PK urine samples were collected at pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
AUC (0-infinity) of Plasma Gepotidacin for Part 3 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
AUC (0-t) of Plasma Gepotidacin for Part 3 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Cmax of Plasma Gepotidacin for Part 3 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Tmax of Plasma Gepotidacin for Part 3 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Tlag of Plasma Gepotidacin for Part 3 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
t1/2 of Plasma Gepotidacin for Part 3 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period]
Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Total Unchanged Drug (Ae Total) for Part 3 [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours]
PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher
Urine Ae (t1-t2) for Part 3 [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.]
PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Only those participants available at the specific time points were analyzed (represented by n = X in the category titles).
Urine AUC (0-12) for Part 3 [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.]
PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Urine AUC (0-24) for Part 3 [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.]
PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Urine AUC (0-48) for Part 3 [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.]
PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
fe% for Part 3 [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.]
PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
CLr for Part 3 [Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.]
PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher

Secondary Outcome Measures

Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1a [Up to 14 days]
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Participants with non-serious AEs and SAEs has been reported. Safety Population comprised of all participants who received at least 1 dose of study medication and had at least 1 post dose safety assessment.
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a [Baseline and up to 14 days]
Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a [Baseline and up to 14 days]
Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a [Baseline and up to 14 days]
Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a [Baseline and up to 14 days]
Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin, serum creatinine and serum direct bilirubin Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a [Baseline and up to 14 days]
Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a [Baseline and up to 14 days]
Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Hemoglobin (MCH) for Part 1a [Baseline and up to 14 days]
Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 1a [Baseline and up to 14 days]
Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Hematology Parameter Blood Ery. for Part 1a [Baseline and up to 14 days]
Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1a [Baseline and up to 14 days]
Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a [Baseline and up to 14 days]
Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a [Baseline and up to 14 days]
Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a [Baseline and up to 14 days]
A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) for Part 1a [Baseline and up to 14 days]
A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 1a. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a [Up to 14 days]
Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 1a. Only categories with significant values have been presented.
Number of Participants With AEs and SAEs for Part 1b [Up to 11 days]
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1b [Baseline and up to 11 days]
Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 1b [Baseline and up to 11 days]
Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1b [Baseline and up to 11 days]
Blood samples were collected for the assessment of chemistry parameters namely serum albuim and serum protein for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin in Part 1b [Baseline and up to 11 days]
Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1b [Baseline and up to 11 days]
Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 1b [Baseline and up to 11 days]
Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 1b [Baseline and up to 11 days]
Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Hematology Parameter Blood Ery. MCV for Part 1b [Baseline and up to 11 days]
Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Hematology Parameter Blood Ery. for Part 1b [Baseline and up to 11 days]
Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1b [Baseline and up to 11 days]
Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Vital Sign Parameters SBP and DBP for Part 1b [Baseline and up to 11 days]
Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Vital Sign Parameter Heart Rate for Part 1b [Baseline and up to 11 days]
Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in ECG Parameter Heart Rate for Part 1b [Baseline and up to 11 days]
A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 1b [Baseline and up to 11 days]
A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 1b. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1b [Up to 11 days]
Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Number of Participants With Non-serious AEs and SAEs for Part 2 [Up to 11 days]
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2 [Baseline and up to 11 days]
Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2 [Baseline and up to 11 days]
Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2 [Baseline and up to 11 days]
Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2 [Baseline and up to 11 days]
Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin, serum creatinine and serum direct bilirubin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Clinical Chemistry Parameter Serum Estradiol for Part 2 [Baseline and up to 11 days]
Blood samples were collected for the assessment of chemistry parameter namely serum estradiol for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the indicated time point were analyzed. NA indicates standard deviation was not calculated as a single participant was analyzed.
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2 [Baseline and up to 11 days]
Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Hematology Parameters Ery. MCHC and Blood Hemoglobin for Part 2 [Baseline and up to 11 days]
Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 2 [Baseline and up to 11 days]
Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Hematology Parameter Blood Ery. MCV for Part 2 [Baseline and up to 11 days]
Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Hematology Parameter Blood Ery. for Part 2 [Baseline and up to 11 days]
Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2 [Baseline and up to 11 days]
Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2 [Baseline and up to 11 days]
Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Vital Sign Parameter Heart Rate for Part 2 [Baseline and up to 11 days]
Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in ECG Parameter Heart Rate for Part 2 [Baseline and up to 11 days]
A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2 [Baseline and up to 11 days]
A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 2. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2 [Baseline and up to 11 days]
Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 4+ 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 2. Only categories with significant values have been presented.
Number of Participants With Non-serious AEs and SAEs for Part 3 [Up to 14 days]
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3 [Baseline and up to 14 days]
Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3 [Baseline and up to 14 days]
Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3 [Baseline and up to 14 days]
Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3 [Baseline and up to 14 days]
Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin and serum creatinine for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3 [Baseline and up to 14 days]
Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3 [Baseline and up to 14 days]
Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 3 [Baseline and up to 14 days]
Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 3 [Baseline and up to 14 days]
Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Hematology Parameter Blood Ery. for Part 3 [Baseline and up to 14 days]
Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 3 [Baseline and up to 14 days]
Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3 [Baseline and up to 14 days]
Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Vital Sign Parameter Heart Rate for Part 3 [Baseline and up to 14 days]
Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in ECG Parameter Heart Rate for Part 3 [Baseline and up to 14 days]
A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3 [Baseline and up to 14 days]
A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 3. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3 [Up to 14 days]
Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 3. Only categories with significant values have been presented.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria

Male or female subjects between 18 and 64 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by the investigator based on medical history, clinical laboratory results (serum chemistry, hematology, urinalysis, and serology), vital sign measurements, 12-lead ECG results, and physical examination findings. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator feels and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Additional inclusion criteria for Japanese subjects (Part 2a only): the subject was a non-naturalized Japanese citizen and held a Japanese passport, the subject had 2 Japanese parents and 4 Japanese grandparents who were all non naturalized Japanese citizens, as confirmed by interview and the subject had been living outside of Japan for up to 10 years as confirmed by interview.
Additional inclusion criteria for Chinese subjects (Part 2b only): the subject was a non-naturalized Chinese citizen and held a Chinese passport, the subject had 2 Chinese parents and 4 Chinese grandparents who were all non naturalized Chinese citizens, as confirmed by interview, the subject had been living outside of China for up to 10 years as confirmed by interview.
Body weight for subjects in Part 1a and 1b: more than equal to (>=) 50 kilogram (kg) and body mass index (BMI) within the range 19 and 32 kilogram per meter square (kg/m^{2), inclusive and for Japanese and Chinese subjects (Part 2a and 2b): >=50 kg
and BMI within the range 18 and 32 kg/m}2, inclusive.
Male or female: a female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin test, not lactating, and at least one of the following conditions applies. Non-reproductive potential defined as: pre-menopausal females with one of the following: documented tubal ligation, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, hysterectomy, documented bilateral oophorectomy and postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle-stimulating hormone and estradiol levels consistent with menopause). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential from 30 days prior to the first dose of study medication and until completion of the Follow-up visit.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

Exclusion Criteria

Subject has a clinically significant abnormality in past medical history or at the Screening physical examination that in the investigator's opinion may place the subject at risk or interfere with outcome variables of the study. This includes, but is not limited to, history or current cardiac, hepatic, renal, neurologic, gastrointestinal, respiratory, hematologic, or immunologic disease.
Subject has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug, or any other condition that may place the subject at risk, in the opinion of the investigator.
QTc more than (>) 450 millisecond (msec).
Use of a systemic antibiotic within 30 days of Screening.
Within 2 months before Screening, either a confirmed history of Clostridium difficile diarrhea infection or a past positive Clostridium difficile toxin test.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of sensitivity to heparin or heparin-induced thrombocytopenia (if the clinic uses heparin to maintain intravenous cannula patency).
Subjects cannot use any over-the-counter, or prescription medication (except for hormonal contraceptives and/or acetaminophen), vitamin supplement, or herbal medication within 7 days (or 5 half-lives, whichever is longer) before dosing and during the study.
History of regular alcohol consumption within 6 months of screening defined as an average weekly intake of >21 units (or an average daily intake of >3 units) for males or an average weekly intake of >14 units (or an average daily intake >2 units) for females. One unit is equivalent to 270 milliliter (mL) of full strength beer, 470 mL of light beer, 30 mL of spirits, or 100 mL of wine.
Urinary cotinine level indicative of smoking or history or regular use of tobacco- or nicotine containing products within 3 months before screening.
History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
Presence of hepatitis B surface antigen, positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
Female subject has a positive pregnancy test result or is lactating at Screening or upon admission to the clinic.
ALT >1.5×upper limit of normal (ULN)
Bilirubin >1.5×ULN (isolated bilirubin >1.5×ULN is acceptable if bilirubin is fractionated and direct bilirubin less than [<] 35 percent [%]).
Urinalysis positive for blood without other cause identified.
A positive pre-study drug/alcohol screen.
A positive test for human immunodeficiency virus antibody.
Subject has clinically significant abnormal findings in serum chemistry, hematology, or urinalysis results obtained at Screening or Day -1.
Donation of blood in excess of 500 mL within 12 weeks prior to dosing or participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Previous exposure to gepotidacin within 12 months prior to the first dosing day.
Exclusion criteria for screening and baseline 12-lead ECG (a single repeat is allowed for eligibility determination): male subjects with heart rate <40 and >100 beats per minute (bpm), female subjects with heart rate <50 and >100 bpm, PR interval <120 and

220 msec for male and female subjects, QRS duration <70 and >120 msec in both male and female subjects and corrected QT interval using Bazett's formula (QTcB) or corrected QT interval using Fridericia's formula (QTcF) >450 msec in both male and female subjects. Evidence of previous myocardial infarction (does not include ST segment changes associated with repolarization). Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular block [second degree or higher], Wolf Parkinson White syndrome), sinus pauses >3 seconds, non-sustained or sustained ventricular tachycardia (>=3 consecutive ventricular ectopic beats) or any significant arrhythmia which, in the opinion of the principal investigator and GlaxoSmithKline medical monitor, will interfere with the safety of the individual subject.

The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Subject is unable to comply with all study procedures, in the opinion of the investigator.
The subject should not participate in the study, in the opinion of the investigator or sponsor.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Anaheim	California	United States	92801
2	GSK Investigational Site	Austin	Texas	United States	78744

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT02853435

Other Study ID Numbers:

117351

First Posted:

Aug 3, 2016

Last Update Posted:

Oct 8, 2020

Last Verified:

Sep 1, 2020

Keywords provided by GlaxoSmithKline

Cross-over

Gepotidacin

Pharmacokinetics

Relative Bioavailability

non-compartmental PK analysis

High shear wet granulation

Additional relevant MeSH terms:

Bacterial Infections

Study Results

Participant Flow

Recruitment Details	This study was conducted across 2 centers in the United States from 04-August-2016 to 18-October-2017. Since the relative bio-availability of the roller compacted(RC) tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Pre-assignment Detail	A total of 48 participants were enrolled in the study of which 26 participants were randomized in Part 1a, 10 participants were randomized in Part 2 and 12 participants were part of Placebo-controlled Part 3.

Arm/Group Title	Gepotidacin-R Then Gepotidacin RC Then Gepotidacin HSWG	Gepotidacin HSWG Then Gepotidacin- R Then Gepotidacin RC	Gepotidacin-RC Then Gepotidacin HSWG Then Gepotidacin-R	Gepotidacin 1500 mg RC Then Gepotidacin 3000 mg RC	Gepotidacin 1500 Then Gepotidacin 2250 Then Gepotidacin 3000	Placebo Then Placebo Then Placebo
Arm/Group Description	Participants received gepotidacin 1500 milligrams (mg) (3 x 500 mg) (Reference [R]) capsules in treatment period 1 followed by gepotidacin 1500 mg (2 x 750 mg) related RC tablets in treatment period 2 followed by gepotidacin 1500 mg (2 x 750 mg) high shear wet granulation (HSWG) tablets orally for 3 days in each treatment period in Part 1a. There was a washout period of at least 3 days between the doses.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets in treatment period 1 followed by gepotidacin 1500 mg (3 x 500 mg) - R capsules in treatment Period 2 followed by gepotidacin 1500 mg (2 x 750 mg) RC tablets in treatment period 3 orally for 3 days in each treatment period in Part 1a. There was a washout period of at least 3 days between the doses.	Participants received gepotidacin 1500 mg (2 x 750 mg) RC tablets in treatment period 1 followed by gepotidacin 1500 mg (2 x 750 mg) HSWG tablets in treatment period 2 followed by gepotidacin 1500 mg (3 x 500 mg) - R capsules in treatment period 3 for 3 days in each treatment period in Part 1a. There was a washout period of at least 3 days between the doses.	Participants received gepotidacin 1500 mg (2 x 750 mg) RC tablets in treatment period 1 followed by gepotidacin 3000 mg (4 x 750 mg) RC tablets in treatment period 2 orally for 3 days in each treatment period in Part 2. There was a washout period of at least 3 days between the doses.	Participants received gepotidacin 1500 mg (2 x 750 mg) RC tablets - fed in treatment period 1 followed by Gepotidacin 2250 mg (3 x 750 mg) RC tablets - fed in treatment period 2 followed by Gepotidacin 2250 mg (3 x 750 mg) RC tablets - fed in treatment period 3 orally for 3 days in each treatment period in part 3. There was a washout period of at least 3 days between the doses.	Participants received matching placebo to gepotidacin 1500 mg RC tablets in treatment period 1 followed by matching placebo to gepotidacin 2250 mg in treatment period 2 followed by matching placebo to gepotidacin 2250 mg RC tablets in treatment period 3 orally for 3 days in each treatment Period in Part 3. There was a washout period of at least 3 days between the doses.
Period Title: Part 1a, Period 1 (3 Days)
STARTED	9	9	8	0	0	0
COMPLETED	9	9	8	0	0	0
NOT COMPLETED	0	0	0	0	0	0
Period Title: Part 1a, Period 1 (3 Days)
STARTED	9	9	8	0	0	0
COMPLETED	9	9	8	0	0	0
NOT COMPLETED	0	0	0	0	0	0
Period Title: Part 1a, Period 1 (3 Days)
STARTED	9	9	8	0	0	0
COMPLETED	9	9	8	0	0	0
NOT COMPLETED	0	0	0	0	0	0
Period Title: Part 1a, Period 1 (3 Days)
STARTED	9	9	8	0	0	0
COMPLETED	9	9	8	0	0	0
NOT COMPLETED	0	0	0	0	0	0
Period Title: Part 1a, Period 1 (3 Days)
STARTED	9	9	8	0	0	0
COMPLETED	9	9	8	0	0	0
NOT COMPLETED	0	0	0	0	0	0
Period Title: Part 1a, Period 1 (3 Days)
STARTED	0	0	0	10	0	0
COMPLETED	0	0	0	10	0	0
NOT COMPLETED	0	0	0	0	0	0
Period Title: Part 1a, Period 1 (3 Days)
STARTED	0	0	0	10	0	0
COMPLETED	0	0	0	10	0	0
NOT COMPLETED	0	0	0	0	0	0
Period Title: Part 1a, Period 1 (3 Days)
STARTED	0	0	0	10	0	0
COMPLETED	0	0	0	10	0	0
NOT COMPLETED	0	0	0	0	0	0
Period Title: Part 1a, Period 1 (3 Days)
STARTED	0	0	0	0	10	2
COMPLETED	0	0	0	0	10	2
NOT COMPLETED	0	0	0	0	0	0
Period Title: Part 1a, Period 1 (3 Days)
STARTED	0	0	0	0	10	2
COMPLETED	0	0	0	0	10	2
NOT COMPLETED	0	0	0	0	0	0
Period Title: Part 1a, Period 1 (3 Days)
STARTED	0	0	0	0	10	2
COMPLETED	0	0	0	0	10	2
NOT COMPLETED	0	0	0	0	0	0
Period Title: Part 1a, Period 1 (3 Days)
STARTED	0	0	0	0	10	2
COMPLETED	0	0	0	0	9	2
NOT COMPLETED	0	0	0	0	1	0
Period Title: Part 1a, Period 1 (3 Days)
STARTED	0	0	0	0	9	2
COMPLETED	0	0	0	0	9	2
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Total Participants-Part 1a	Total Participants-Part 2	Total Participants- Part 3	Total
Arm/Group Description	Participants received gepotidacin 1500 mg (3 x 500 mg) capsules, gepotidacin 1500 mg (2 x 750 mg) RC tablets and gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in a cross-over manner. There was a washout period of at least 3 days between the doses.	Participants received gepotidacin 1500 mg (2 x 750 mg) RC tablets and gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in one of the 2 treatment periods in a cross-over manner. There was a washout period of at least 3 days between the doses.	Participants received gepotidacin 1500 mg (2 x 750 mg) RC tablets - fed, gepotidacin 2250 mg (3 x 750 mg) RC tablets - fed and gepotidacin 3000 mg (4 x 750 mg) RC tablets - fed orally in one of the 3 treatment periods in a cross-over manner. There was a washout period of at least 3 days between the doses.	Total of all reporting groups
Overall Participants	26	10	12	48
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	39.5 (10.64)	55.6 (6.43)	37.8 (7.93)	42.5 (11.39)
Sex: Female, Male (Count of Participants)
Female	5 19.2%	8 80%	6 50%	19 39.6%
Male	21 80.8%	2 20%	6 50%	29 60.4%
Race/Ethnicity, Customized (Count of Participants)
Black or African American	10 38.5%	0 0%	0 0%	10 20.8%
White - White/Caucasian/European Heritage	16 61.5%	0 0%	0 0%	16 33.3%
Asian - Japanese Heritage	0 0%	10 100%	12 100%	22 45.8%

Outcome Measures

1. Primary Outcome

Title	Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of Plasma Gepotidacin for Part 1a
Description	Blood samples for pharmacokinetic (PK) analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 milliliters (mL) of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. The PK Parameter Population consisted of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. Statistics has been presented on geometric least square (LS) means.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in Part 1a.
Measure Participants	26	26	26
Geometric Mean (Geometric Coefficient of Variation) [hours*nanograms/milliliter]	16733 (25.7)	17495 (23.0)	18646 (24.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gepotidacin 1500 mg - R Capsules, Gepotidacin 1500 mg RC Tablets
	Comments
	Type of Statistical Test	Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio of geometric LS means
	Estimated Value	1.0417
	Confidence Interval	(2-Sided) 90% 0.9809 to 1.1063
	Parameter Dispersion	Type: Value:
	Estimation Comments	A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-inf).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gepotidacin 1500 mg - R Capsules, Gepotidacin 1500 mg HSWG Tablets
	Comments
	Type of Statistical Test	Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio of geometric LS means
	Estimated Value	1.1108
	Confidence Interval	(2-Sided) 90% 1.0459 to 1.1797
	Parameter Dispersion	Type: Value:
	Estimation Comments	A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-inf).

2. Primary Outcome

Title	Area Under the Concentration-time Curve (AUC) From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC [0-t]) of Plasma Gepotidacin for Part 1a
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Statistics has been presented on geometric LS means.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in Part 1a.
Measure Participants	26	26	26
Geometric Mean (Geometric Coefficient of Variation) [hours*nanograms/milliliters]	16409 (26.2)	17125 (23.4)	18317 (24.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gepotidacin 1500 mg - R Capsules, Gepotidacin 1500 mg RC Tablets
	Comments
	Type of Statistical Test	Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio of geometric LS means
	Estimated Value	1.0408
	Confidence Interval	(2-Sided) 90% 0.9792 to 1.1062
	Parameter Dispersion	Type: Value:
	Estimation Comments	A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-t).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gepotidacin 1500 mg - R Capsules, Gepotidacin 1500 mg HSWG Tablets
	Comments
	Type of Statistical Test	Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio of geometric LS means
	Estimated Value	1.1138
	Confidence Interval	(2-Sided) 90% 1.0479 to 1.1838
	Parameter Dispersion	Type: Value:
	Estimation Comments	A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-t).

3. Primary Outcome

Title	Relative Bioavailability of Drug (Frel) of Plasma Gepotidacin for Part 1a
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. NA indicates data was not available as this was the reference capsule the Frel of each tablet type was being compared to.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in Part 1a.
Measure Participants	26	26	26
Geometric Mean (Geometric Coefficient of Variation) [Ratio of AUC (0-infinity)]	NA (NA)	1.05 (22.3)	1.11 (16.5)

4. Primary Outcome

Title	Maximum Observed Concentration (Cmax) Determined Directly From the Concentration Time Data of Plasma Gepotidacin for Part 1a
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Statistics has been presented on geometric LS means.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in Part 1a.
Measure Participants	26	26	26
Geometric Mean (Geometric Coefficient of Variation) [nanograms/milliliter]	4648 (43.8)	4487 (43.6)	5349 (46.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gepotidacin 1500 mg - R Capsules, Gepotidacin 1500 mg RC Tablets
	Comments
	Type of Statistical Test	Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio of geometric LS means
	Estimated Value	0.9586
	Confidence Interval	(2-Sided) 90% 0.8440 to 1.0888
	Parameter Dispersion	Type: Value:
	Estimation Comments	A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters Cmax.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gepotidacin 1500 mg - R Capsules, Gepotidacin 1500 mg HSWG Tablets
	Comments
	Type of Statistical Test	Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio of geometric LS means
	Estimated Value	1.1487
	Confidence Interval	(2-Sided) 90% 1.0113 to 1.3047
	Parameter Dispersion	Type: Value:
	Estimation Comments	A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters Cmax.

5. Primary Outcome

Title	Time to First Occurrence of Cmax (Tmax) of Plasma Gepotidacin for Part 1a
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in Part 1a.
Measure Participants	26	26	26
Median (Full Range) [hours]	1.50	1.50	1.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gepotidacin 1500 mg - R Capsules, Gepotidacin 1500 mg RC Tablets
	Comments
	Type of Statistical Test	Other
	Comments

Statistical Test of Hypothesis	p-Value	0.309
	Comments	The p-value is from Wilcoxon signed-rank test.
	Method	Wilcoxon signed-rank test.
	Comments

Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-0.233
	Confidence Interval	(2-Sided) 90% -0.267 to 0.000
	Parameter Dispersion	Type: Value:
	Estimation Comments	The median, median difference and 90% CI of the median difference are from Hodge-Lehmann estimate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gepotidacin 1500 mg - R Capsules, Gepotidacin 1500 mg HSWG Tablets
	Comments
	Type of Statistical Test	Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The p-value is from Wilcoxon signed-rank test.
	Method	Wilcoxon signed-rank test.
	Comments

Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-0.492
	Confidence Interval	(2-Sided) 90% -0.500 to -0.250
	Parameter Dispersion	Type: Value:
	Estimation Comments	The median, median difference and 90% CI of the median difference are from Hodge-Lehmann estimate.

6. Primary Outcome

Title	Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of Plasma Gepotidacin for Part 1a
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in Part 1a.
Measure Participants	26	26	26
Median (Full Range) [hours]	0.00	0.00	0.00

7. Primary Outcome

Title	Terminal Phase Half-life (t1/2) of Plasma Gepotidacin for Part 1a
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in Part 1a.
Measure Participants	26	26	26
Geometric Mean (Geometric Coefficient of Variation) [hours]	10.29 (13.7)	10.24 (15.2)	10.24 (12.1)

8. Primary Outcome

Title	Total Unchanged Drug (Total Amount of Drug Excreted in Urine [Ae Total]) for Part 1a
Description	PK urine samples were collected at 0 (predose), 0 to 2, 2 ot 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in Part 1a.
Measure Participants	26	26	26
Geometric Mean (Geometric Coefficient of Variation) [milligrams]	274.925 (28.6)	286.751 (22.2)	284.510 (30.0)

9. Primary Outcome

Title	Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Plasma Gepotidacin for Part 1a
Description	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in Part 1a.
Measure Participants	26	26	26
Geometric Mean (Geometric Coefficient of Variation) [Percentage dose of drug excreted]	18.329 (28.6)	19.116 (22.2)	18.968 (30.0)

10. Primary Outcome

Title	Renal Clearance of Drug in Urine (CLr) for Part 1a
Description	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in Part 1a.
Measure Participants	26	26	26
Geometric Mean (Geometric Coefficient of Variation) [liters/hour]	16.761 (21.7)	16.740 (19.6)	15.532 (22.3)

11. Primary Outcome

Title	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a
Description	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Only those participants available at the specific time points were analyzed (represented by n = X in the category titles).
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in Part 1a.
Measure Participants	26	26	26
Ae (0-2), n=26,25,26	65.817 (95.1)	60.915 (102.9)	85.584 (67.7)
Ae (2-4),n=26,24,25	72.734 (67.3)	77.650 (33.6)	67.419 (72.0)
Ae (4-6),n=25,25,26	36.019 (44.2)	45.313 (61.1)	39.361 (39.1)
Ae (6-8),n=25,26,26	22.817 (37.4)	26.061 (24.9)	22.755 (28.7)
Ae (8-12),n=26,26,26	21.515 (57.3)	25.609 (27.7)	16.590 (75.5)
Ae (12-24),n=26,26,26	19.224 (60.4)	22.536 (26.9)	19.432 (32.9)
Ae (24-36),n=26,26,26	8.145 (35.0)	9.787 (27.8)	8.185 (44.4)
Ae (36-48),n=26,26,26	4.633 (31.4)	4.517 (57.7)	4.319 (41.0)

12. Primary Outcome

Title	Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 12 Hours (AUC [0-12]) for Part 1a
Description	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in Part 1a.
Measure Participants	26	26	26
Geometric Mean (Geometric Coefficient of Variation) [micrograms*hours/milliliter]	1904 (82.7)	1948 (61.2)	2156 (74.8)

13. Primary Outcome

Title	Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 24 Hours (AUC [0-24]) After Dosing for Part 1a
Description	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in Part 1a.
Measure Participants	26	26	262
Geometric Mean (Geometric Coefficient of Variation) [micrograms*hours/milliliter]	2373 (74.9)	2464 (56.3)	2599 (69.0)

14. Primary Outcome

Title	Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 48 Hours (AUC [0-48]) After Dosing for Part 1a
Description	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Only those participants with data available at the indicated time point were analyzed.
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours

Outcome Measure Data

Analysis Population Description
PK Parameter Population.

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in Part 1a.
Measure Participants	23	26	24
Geometric Mean (Geometric Coefficient of Variation) [micrograms*hours/milliliter]	2597 (69.5)	2725 (54.4)	2768 (64.0)

15. Primary Outcome

Title	AUC (0-infinity) of Plasma Gepotidacin for Part 1b
Description	Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population. The relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

16. Primary Outcome

Title	AUC (0-t) of Plasma Gepotidacin for Part 1b
Description	Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population. The relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

17. Primary Outcome

Title	Cmax of Plasma Gepotidacin for Part 1b
Description	Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population. The relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

18. Primary Outcome

Title	Tmax of Plasma Gepotidacin for Part 1b
Description	Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population. The relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

19. Primary Outcome

Title	Tlag of Plasma Gepotidacin for Part 1b
Description	Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population. The relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

20. Primary Outcome

Title	t1/2 of Plasma Gepotidacin for Part 1b
Description	Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population. The relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

21. Primary Outcome

Title	AUC (0-infinity) of Plasma Gepotidacin for Part 2
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Geometric Mean (Geometric Coefficient of Variation) [hours*nanograms/milliliter]	23137 (34.1)	46537 (20.9)

22. Primary Outcome

Title	AUC (0-t) of Plasma Gepotidacin for Part 2
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2
Measure Participants	10	10
Geometric Mean (Geometric Coefficient of Variation) [hours*nanograms/milliliter]	22777 (34.4)	46120 (21.1)

23. Primary Outcome

Title	Cmax of Plasma Gepotidacin for Part 2
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2
Measure Participants	10	10
Geometric Mean (Geometric Coefficient of Variation) [nanograms/milliliter]	9177 (94.8)	15335 (28.6)

24. Primary Outcome

Title	Tlag of Plasma Gepotidacin for Part 2
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Median (Full Range) [hours]	0.00	0.00

25. Primary Outcome

Title	Tmax of Plasma Gepotidacin for Part 2
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Median (Full Range) [hours]	1.00	0.56

26. Primary Outcome

Title	t1/2 of Plasma Gepotidacin for Part 2
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Geometric Mean (Geometric Coefficient of Variation) [hours]	10.73 (10.9)	8.81 (8.4)

27. Primary Outcome

Title	Total Unchanged Drug (Ae Total) for Part 2
Description	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Geometric Mean (Geometric Coefficient of Variation) [milligrams]	203.853 (38.8)	546.263 (51.8)

28. Primary Outcome

Title	Ae (t1-t2) for Part 2
Description	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000mg (4 x 750 mg) RC tablets orally in Part 2 Period 2
Measure Participants	10	10
Ae (0-2)	50.893 (289.7)	115.793 (73.0)
Ae (2-4)	47.995 (42.7)	131.013 (92.1)
Ae (4-6)	21.381 (47.5)	97.651 (139.4)
Ae (6-8)	11.759 (88.2)	40.670 (36.2)
Ae (8-12)	12.519 (104.6)	29.474 (96.0)
Ae (12-24)	9.810 (226.4)	30.849 (83.9)
Ae (24-36)	3.710 (111.0)	9.754 (51.0)
Ae (36-48)	2.743 (114.7)	3.652 (136.1)

29. Primary Outcome

Title	AUC (0-12) for Part 2
Description	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Geometric Mean (Geometric Coefficient of Variation) [micrograms*hours/milliliter]	1298 (110.8)	4758 (64.6)

30. Primary Outcome

Title	AUC (0-24) for Part 2
Description	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Geometric Mean (Geometric Coefficient of Variation) [micrograms*hours/milliliter]	1714 (88.8)	5594 (61.9)

31. Primary Outcome

Title	AUC (0-48) for Part 2
Description	PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Geometric Mean (Geometric Coefficient of Variation) [micrograms*hours/milliliter]	1875 (83.6)	5845 (61.1)

32. Primary Outcome

Title	fe% for Part 2
Description	PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Geometric Mean (Geometric Coefficient of Variation) [Percentage dose of drug excreted]	13.591 (38.8)	18.207 (51.8)

33. Primary Outcome

Title	CLr for Part 2
Description	PK urine samples were collected at pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Geometric Mean (Geometric Coefficient of Variation) [liters/hour]	8.950 (41.5)	11.834 (32.0)

34. Primary Outcome

Title	AUC (0-infinity) of Plasma Gepotidacin for Part 3
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.
Measure Participants	10	10	9
Geometric Mean (Geometric Coefficient of Variation) [hours*nanograms/milliliter]	22921 (19.9)	37235 (17.2)	50178 (21.9)

35. Primary Outcome

Title	AUC (0-t) of Plasma Gepotidacin for Part 3
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.
Measure Participants	10	10	9
Geometric Mean (Geometric Coefficient of Variation) [hours*nanograms/milliliter]	22709 (20.0)	36938 (17.2)	49789 (21.7)

36. Primary Outcome

Title	Cmax of Plasma Gepotidacin for Part 3
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.
Measure Participants	10	10	9
Geometric Mean (Geometric Coefficient of Variation) [nanograms/milliliter]	6502 (27.7)	9812 (21.1)	12889 (21.1)

37. Primary Outcome

Title	Tmax of Plasma Gepotidacin for Part 3
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.
Measure Participants	10	10	9
Median (Full Range) [hours]	2.25	2.05	2.00

38. Primary Outcome

Title	Tlag of Plasma Gepotidacin for Part 3
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.
Measure Participants	10	10	9
Median (Full Range) [hours]	0.50	0.00	0.00

39. Primary Outcome

Title	t1/2 of Plasma Gepotidacin for Part 3
Description	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.
Measure Participants	10	10	9
Geometric Mean (Geometric Coefficient of Variation) [hours]	9.23 (9.7)	8.19 (7.2)	7.93 (10.6)

40. Primary Outcome

Title	Total Unchanged Drug (Ae Total) for Part 3
Description	PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.
Measure Participants	10	10	9
Geometric Mean (Geometric Coefficient of Variation) [milligrams]	390.099 (34.3)	613.635 (32.2)	895.556 (27.8)

41. Primary Outcome

Title	Urine Ae (t1-t2) for Part 3
Description	PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Only those participants available at the specific time points were analyzed (represented by n = X in the category titles).
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.
Measure Participants	10	10	9
Ae (0-2), n=10,10,9	27.763 (536.8)	54.827 (264.1)	142.546 (96.7)
Ae (2-4), n=10,10,9	132.423 (67.6)	247.448 (45.5)	333.805 (43.0)
Ae (4-6),n=9,10,9	63.314 (61.4)	113.386 (36.9)	175.739 (36.5)
Ae (6-8),n=10,10,9	54.631 (57.4)	48.536 (93.3)	70.582 (70.7)
Ae (8-12),n=10,10,9	35.322 (37.1)	48.906 (41.0)	47.392 (85.2)
Ae (12-24),n=10,10,9	14.201 (40.3)	22.931 (65.9)	36.214 (65.8)
Ae (24-36),n=10,10,9	6.510 (49.0)	8.463 (55.4)	12.642 (50.7)
Ae (36-48),n=10,10,8	3.265 (53.3)	3.150 (71.5)	5.641 (42.4)

42. Primary Outcome

Title	Urine AUC (0-12) for Part 3
Description	PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.
Measure Participants	10	10	9
Geometric Mean (Geometric Coefficient of Variation) [micrograms*hours/milliliter]	1573 (48.3)	2812 (42.4)	3517 (52.4)

43. Primary Outcome

Title	Urine AUC (0-24) for Part 3
Description	PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.
Measure Participants	10	10	9
Geometric Mean (Geometric Coefficient of Variation) [micrograms*hours/milliliter]	1879 (51.8)	3301 (45.5)	4197 (54.1)

44. Primary Outcome

Title	Urine AUC (0-48) for Part 3
Description	PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.
Measure Participants	10	10	9
Geometric Mean (Geometric Coefficient of Variation) [micrograms*hours/milliliter]	2024 (54.3)	3455 (46.6)	4390 (54.1)

45. Primary Outcome

Title	fe% for Part 3
Description	PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.
Measure Participants	10	10	9
Geometric Mean (Geometric Coefficient of Variation) [Percentage dose of drug excreted]	26.008 (34.3)	27.273 (32.2)	29.858 (27.8)

46. Primary Outcome

Title	CLr for Part 3
Description	PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher
Time Frame	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Outcome Measure Data

Analysis Population Description
PK Parameter Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.
Measure Participants	10	10	9
Geometric Mean (Geometric Coefficient of Variation) [liters/hour]	17.196 (24.8)	16.598 (26.5)	17.969 (21.2)

47. Secondary Outcome

Title	Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1a
Description	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Participants with non-serious AEs and SAEs has been reported. Safety Population comprised of all participants who received at least 1 dose of study medication and had at least 1 post dose safety assessment.
Time Frame	Up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
Measure Participants	26	26	26
Non serious AE	8 30.8%	5 50%	9 75%
SAE	0 0%	0 0%	0 0%

48. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a
Description	Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
Measure Participants	26	26	26
Serum glucose, Day 3 (48 hour), n=26, 26, 26	0.010 (0.2837)	0.049 (0.3253)	0.094 (0.2699)
Serum glucose, Follow-up, n=8, 9, 9	0.099 (0.3911)	0.304 (0.5180)	0.381 (0.3850)
Serum calcium, Day 3 (48 hour), n=26, 26, 26	0.050 (0.0968)	0.054 (0.0802)	0.051 (0.0700)
Serum calcium, Follow-up, n=8, 9, 9	0.003 (0.0861)	-0.019 (0.0692)	-0.046 (0.0865)
Serum carbon dioxide, Day 3 (48 hour),n=26, 26, 26	-0.2 (1.39)	-0.2 (1.22)	0.0 (1.22)
Serum carbon dioxide, Follow-up, n=8, 9, 9	-1.4 (1.19)	-1.7 (1.58)	-1.6 (1.33)
Serum chloride, Day 3 (48 hour),n=26, 26, 26	-1.0 (1.78)	-1.1 (2.00)	-1.0 (2.27)
Serum chloride, Follow-up, n=8, 9, 9	1.3 (1.75)	0.7 (1.32)	1.6 (2.24)
Serum potassium, Day 3 (48 hour), n=26,26,26	-0.06 (0.297)	-0.04 (0.270)	-0.06 (0.298)
Serum potassium, Follow-up, n=8,9,9,	-0.18 (0.306)	-0.09 (0.237)	-0.24 (0.371)
Serum sodium, Day 3 (48 hour), n=26,26,26	-0.3 (1.70)	-0.7 (1.67)	-0.5 (1.98)
Serum sodium, Follow-up, n=8,9,9	-1.0 (2.39)	-1.3 (2.35)	-0.6 (1.74)
Serum urea nitrogen, Day 3 (48 hour), n=26,26,26	-0.250 (1.0929)	-0.307 (1.0021)	-0.332 (1.0598)
Serum urea nitrogen, Follow-up, n=8,9,9	-0.043 (1.4732)	-0.354 (1.0294)	-0.223 (1.0126)

49. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a
Description	Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
Measure Participants	26	26	26
Serum ALT, Day 3 (48 hour), n=26, 26, 26	-1.1 (7.04)	-0.1 (7.30)	-0.3 (6.54)
Serum ALT, Follow-up, n=8, 9, 9	-3.0 (10.76)	0.1 (11.57)	5.4 (5.05)
Serum AP, Day 3 (48 hour), n=26, 26, 26	7.7 (5.69)	8.3 (5.40)	9.0 (6.25)
Serum AP, Follow-up, n=8, 9, 9	2.6 (6.07)	7.2 (7.71)	7.4 (4.75)
Serum AST, Day 3 (48 hour),n=26, 26, 26	-0.6 (4.11)	-0.2 (4.01)	-0.5 (3.99)
Serum AST, Follow-up, n=8, 9, 9	-0.1 (4.94)	1.7 (7.18)	3.1 (4.40)
Serum CK, Day 3 (48 hour),n=26, 26, 26	-28.7 (43.65)	-26.4 (47.32)	-30.2 (41.96)
Serum CK, Follow-up, n=8, 9, 9	8.0 (42.32)	29.0 (107.27)	13.2 (26.16)

50. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a
Description	Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
Measure Participants	26	26	26
Serum albumin, Day 3 (48 hour), n=26, 26, 26	1.5 (2.27)	1.8 (1.98)	1.8 (2.36)
Serum albumin, Follow-up, n=8, 9, 9	-0.3 (2.55)	-0.7 (1.87)	-0.6 (2.46)
Serum protein, Day 3 (48 hour), n=26, 26, 26	1.8 (4.68)	1.9 (3.10)	2.1 (3.98)
Serum protein, Follow-up, n=8, 9, 9	-2.1 (4.29)	-2.6 (3.32)	-2.1 (4.43)

51. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a
Description	Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin, serum creatinine and serum direct bilirubin Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
Measure Participants	26	26	26
Serum bilirubin, Day 3 (48 hour), n=26, 26, 26	2.08 (2.746)	1.59 (3.511)	1.98 (3.018)
Serum bilirubin, Follow-up, n=8, 9, 9	2.34 (3.608)	-1.08 (1.943)	-1.19 (4.431)
Serum creatinine, Day 3 (48 hour), n=26, 26, 26	1.49 (5.758)	2.14 (6.793)	2.31 (6.564)
Serum creatinine, Follow-up, n=8, 9, 9	4.86 (5.349)	2.28 (9.930)	3.93 (5.859)
Serum direct bilirubin, Day 3 (48 hour),n=26,26,26	0.25 (0.422)	0.17 (0.528)	0.18 (0.482)
Serum direct bilirubin, Follow-up, n=8, 9, 9	0.46 (0.707)	-0.14 (0.384)	-0.09 (0.677)

52. Secondary Outcome

Title	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a
Description	Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
Measure Participants	26	26	26
Blood basophils, Day 3 (48 hour), n=26, 26, 26	0.004 (0.0344)	0.004 (0.0344)	-0.004 (0.0344)
Blood basophils, Follow-up, n=8, 9, 9	0.000 (0.0000)	0.000 (0.0500)	0.000 (0.0000)
Blood eosinophils, Day 3 (48 hour), n=26, 26, 26	0.008 (0.0688)	0.008 (0.0935)	0.004 (0.0958)
Blood eosinophils, Follow-up, n=8, 9, 9	0.025 (0.0463)	0.044 (0.0527)	0.033 (0.1323)
Blood leukocytes, Day 3 (48 hour),n=26, 26, 26	-0.388 (0.7464)	-0.300 (0.6957)	-0.400 (0.6675)
Blood leukocytes, Follow-up, n=8, 9, 9	-0.175 (0.4862)	0.000 (1.2728)	-0.400 (0.3841)
Blood lymphocytes, Day 3 (48 hour),n=26, 26, 26	-0.050 (0.2832)	0.015 (0.3081)	-0.008 (0.4127)
Blood lymphocytes, Follow-up, n=8, 9, 9	0.025 (0.2866)	-0.100 (0.4444)	0.011 (0.2147)
Blood monocytes, Day 3 (48 hour),n=26, 26, 26	-0.065 (0.0977)	-0.069 (0.0970)	-0.096 (0.0871)
Blood monocytes, Follow-up, n=8, 9, 9	0.050 (0.0926)	0.033 (0.1323)	-0.056 (0.0527)
Blood neutrophils, Day 3 (48 hour),n=26, 26, 26	-0.254 (0.5907)	-0.238 (0.5845)	-0.288 (0.4702)
Blood neutrophils, Follow-up, n=8, 9, 9	-0.213 (0.5330)	0.089 (0.7976)	-0.356 (0.4187)
Blood platelets, Day 3 (48 hour),n=26, 26, 26	11.5 (14.76)	17.4 (16.43)	14.5 (17.85)
Blood platelets, Follow-up, n=8, 9, 9	3.8 (17.90)	1.8 (17.89)	9.8 (26.48)

53. Secondary Outcome

Title	Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a
Description	Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
Measure Participants	26	26	26
Blood Ery. MCHC, Day 3 (48 hour), n=26, 26, 26	0.4 (4.78)	0.9 (4.27)	0.4 (5.56)
Blood Ery. MCHC, Follow-up, n=8, 9, 9	2.5 (6.63)	4.1 (3.33)	3.0 (5.52)
Blood hemoglobin, Day 3 (48 hour), n=26, 26, 26	8.0 (7.21)	8.5 (6.59)	8.4 (7.26)
Blood hemoglobin, Follow-up, n=8, 9, 9	-3.8 (6.45)	-4.4 (6.29)	-2.3 (8.03)

54. Secondary Outcome

Title	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Hemoglobin (MCH) for Part 1a
Description	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
Measure Participants	26	26	26
Blood Ery.MCH, Day 3 (48 hour), n=26, 26, 26	-0.03 (0.360)	0.00 (0.280)	-0.02 (0.400)
Blood Ery. MCH, Follow-up, n=8, 9, 9	-0.03 (0.512)	0.14 (0.270)	0.04 (0.317)

55. Secondary Outcome

Title	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 1a
Description	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
Measure Participants	26	26	26
Blood Ery. MCV, Day 3 (48 hour), n=26, 26, 26	-0.21 (0.471)	-0.26 (0.568)	-0.23 (0.586)
Blood Ery. MCV, Follow-up, n=8, 9, 9	-0.73 (0.618)	-0.58 (0.549)	-0.72 (0.800)

56. Secondary Outcome

Title	Change From Baseline in Hematology Parameter Blood Ery. for Part 1a
Description	Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
Measure Participants	26	26	26
Blood Ery. , Day 3 (48 hour), n=26, 26, 26	0.279 (0.2597)	0.293 (0.2450)	0.296 (0.2538)
Blood Ery. , Follow-up, n=8, 9, 9	-0.130 (0.2045)	-0.190 (0.2258)	-0.101 (0.2538)

57. Secondary Outcome

Title	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1a
Description	Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
Measure Participants	26	26	26
Blood hematocrit , Day 3 (48 hour), n=26, 26, 26	2.32 (2.212)	2.43 (2.110)	2.48 (2.200)
Blood hematocrit, Follow-up, n=8, 9, 9	-1.50 (1.628)	-1.87 (1.781)	-1.20 (2.029)

58. Secondary Outcome

Title	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a
Description	Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
Measure Participants	26	26	26
SBP, Day 1 (2 hours), n=26, 26, 26,	1.8 (6.88)	-1.3 (7.24)	1.1 (5.25)
SBP, Day 2 (24 hours), n=26, 26, 26	0.1 (6.82)	-2.8 (10.21)	-1.8 (5.31)
SBP, Day 3 (48 hours), n=26, 26, 26	5.3 (7.93)	-1.3 (7.12)	-0.2 (6.46)
SBP, Follow-up, n=8,9,9	18.0 (11.28)	9.4 (6.09)	6.9 (7.83)
DBP, Day 1 (2 hours), n=26, 26, 26,	3.2 (7.04)	1.0 (5.59)	2.2 (6.34)
DBP, Day 2 (24 hours), n=26, 26, 26	2.3 (8.11)	-0.4 (7.41)	0.0 (6.87)
DBP, Day 3 (48 hours), n=26, 26, 26	2.2 (7.65)	2.8 (6.29)	1.0 (7.19)
DBP, Follow-up, n=8,9,9	8.3 (7.36)	6.4 (5.73)	7.4 (4.85)

59. Secondary Outcome

Title	Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a
Description	Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
Measure Participants	26	26	26
Heart rate, Day 1 (2 hours), n=26, 26, 26,	-0.7 (7.59)	0.0 (4.61)	1.7 (3.61)
Heart rate, Day 2 (24 hours), n=26, 26, 26	-0.7 (7.11)	0.6 (5.87)	1.7 (3.82)
Heart rate, Day 3 (48 hours), n=26, 26, 26	-0.2 (8.18)	-0.2 (6.20)	3.2 (5.46)
Heart rate, Follow-up, n=8,9,9	-0.1 (3.04)	0.2 (7.56)	5.7 (5.15)

60. Secondary Outcome

Title	Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a
Description	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
Measure Participants	26	26	26
ECG Heart rate, Day 1 (2 hours), n=26, 26, 26,	-1.1 (6.33)	-1.0 (6.05)	0.4 (3.60)
ECG Heart rate, Day 2 (24 hours), n=26, 26, 26	0.2 (5.85)	-0.4 (8.02)	0.3 (3.96)
ECG Heart rate, Day 3 (48 hours), n=26, 26, 26	0.0 (6.39)	-0.6 (7.00)	1.0 (4.04)
ECG Heart rate, Follow-up, n=8,9,9	-1.0 (4.11)	0.7 (8.82)	3.6 (6.56)

61. Secondary Outcome

Title	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) for Part 1a
Description	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 1a. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
Measure Participants	26	26	26
PR interval, Day 1 (2 hours), n=26, 26, 26	-2.5 (12.28)	-3.2 (11.79)	-3.8 (6.01)
PR interval, Day 2 (24 hours), n=26, 26, 26	1.7 (13.77)	-0.1 (8.80)	-0.5 (9.20)
PR interval,, Day 3 (48 hours), n=26, 26, 26	1.2 (9.64)	-0.3 (7.74)	2.0 (12.51)
PR interval, Follow-up, n=8,9,9	4.0 (14.89)	-3.1 (9.98)	-9.2 (7.41)
QRS duration, Day 1 (2 hours), n=26, 26, 26,	1.3 (4.65)	0.1 (5.61)	-0.4 (4.64)
QRS duration, Day 2 (24 hours), n=26, 26, 26	0.3 (3.64)	-1.0 (5.62)	-0.5 (5.07)
QRS duration, Day 3 (48 hours), n=26, 26, 26	0.1 (4.47)	-0.1 (5.42)	-1.8 (5.28)
QRS duration, Follow-up, n=8,9,9	-0.4 (7.21)	2.1 (8.31)	0.9 (2.26)
QT interval Day 1 (2 hours), n=26, 26, 26,	9.6 (14.42)	6.4 (12.07)	8.8 (11.28)
QT interval, Day 2 (24 hours), n=26, 26, 26	1.5 (11.55)	2.1 (15.22)	2.4 (8.40)
QT interval, Day 3 (48 hours), n=26, 26, 26	1.8 (12.95)	-0.5 (14.55)	-0.7 (10.80)
QT interval, Follow-up, n=8,9,9	17.5 (22.99)	5.2 (29.79)	-3.6 (17.81)
QTcB interval, Day 1 (2 hours), n=26, 26, 26,	6.6 (14.07)	4.3 (14.96)	10.3 (11.26)
QTcB, Day 2 (24 hours), n=26, 26, 26	1.8 (12.63)	1.7 (13.74)	3.8 (9.86)
QTcB, Day 3 (48 hours), n=26, 26, 26	2.0 (12.56)	-1.6 (13.26)	2.9 (9.76)
QTcB, Follow-up, n=8,9,9	13.9 (19.95)	2.9 (19.62)	6.0 (11.51)
QTcF interval, Day 1 (2 hours), n=26, 26, 26,	7.5 (10.56)	4.8 (11.05)	10.0 (9.57)
QTcF, Day 2 (24 hours), n=26, 26, 26	1.7 (9.11)	2.0 (9.73)	3.4 (7.21)
QTcF, Day 3 (48 hours), n=26, 26, 26	2.0 (8.30)	-1.3 (9.93)	1.8 (8.20)
QTcF, Follow-up, n=8,9,9	15.4 (20.16)	4.9 (18.84)	4.6 (7.65)

62. Secondary Outcome

Title	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a
Description	Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 1a. Only categories with significant values have been presented.
Time Frame	Up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin 1500 mg - R Capsules	Gepotidacin 1500 mg RC Tablets	Gepotidacin 1500 mg HSWG Tablets
Arm/Group Description	Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.	Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
Measure Participants	26	26	26
Urine Ketones, Day 3 (48 hours), 1+	1 3.8%	0 0%	0 0%
Urine pH, Day 3 (48 hours), 5+	4 15.4%	4 40%	4 33.3%
Urine pH, Day 3 (48 hours), 6+	18 69.2%	16 160%	14 116.7%
Urine pH, Day 3 (48 hours), 7+	3 11.5%	6 60%	8 66.7%
Urine pH, Day 3 (48 hours), 8+	1 3.8%	0 0%	0 0%
Urine pH, Follow-up, 5+	2 7.7%	4 40%	3 25%
Urine pH, Follow-up, 6+	5 19.2%	5 50%	4 33.3%
Urine pH, Follow-up, 7+	1 3.8%	0 0%	2 16.7%
Urine Specific gravity, Day 3 (48 hours), 1+	26 100%	26 260%	26 216.7%
Urine Specific gravity, Follow-up, 1+	8 30.8%	9 90%	9 75%

63. Secondary Outcome

Title	Number of Participants With AEs and SAEs for Part 1b
Description	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

64. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1b
Description	Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

65. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 1b
Description	Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

66. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1b
Description	Blood samples were collected for the assessment of chemistry parameters namely serum albuim and serum protein for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

67. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin in Part 1b
Description	Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

68. Secondary Outcome

Title	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1b
Description	Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

69. Secondary Outcome

Title	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 1b
Description	Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

70. Secondary Outcome

Title	Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 1b
Description	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

71. Secondary Outcome

Title	Change From Baseline in Hematology Parameter Blood Ery. MCV for Part 1b
Description	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1a.
Measure Participants	0	0

72. Secondary Outcome

Title	Change From Baseline in Hematology Parameter Blood Ery. for Part 1b
Description	Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1a.
Measure Participants	0	0

73. Secondary Outcome

Title	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1b
Description	Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1a.
Measure Participants	0	0

74. Secondary Outcome

Title	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 1b
Description	Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

75. Secondary Outcome

Title	Change From Baseline in Vital Sign Parameter Heart Rate for Part 1b
Description	Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

76. Secondary Outcome

Title	Change From Baseline in ECG Parameter Heart Rate for Part 1b
Description	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

77. Secondary Outcome

Title	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 1b
Description	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 1b. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

78. Secondary Outcome

Title	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1b
Description	Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Time Frame	Up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Arm/Group Title	Gepotidacin 1500 mg RC Tablets-fasted	Gepotidacin 3000 mg RC Tablets-fed
Arm/Group Description	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.	Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
Measure Participants	0	0

79. Secondary Outcome

Title	Number of Participants With Non-serious AEs and SAEs for Part 2
Description	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
Time Frame	Up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Non serious AE	6 23.1%	9 90%
SAE	0 0%	0 0%

80. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2
Description	Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Serum glucose, Day 3 (48 hour)	-0.146 (0.4421)	-0.133 (0.3665)
Serum glucose, Follow-up	NA (NA)	-0.211 (0.5005)
Serum calcium, Day 3 (48 hour)	-0.027 (0.1055)	-0.009 (0.0684)
Serum calcium, Follow-up	NA (NA)	-0.011 (0.0638)
Serum carbon dioxide, Day 3 (48 hour)	1.5 (1.96)	-1.4 (1.71)
Serum carbon dioxide, Follow-up	NA (NA)	-0.4 (1.78)
Serum chloride, Day 3 (48 hour)	-1.5 (1.96)	-1.2 (2.04)
Serum chloride, Follow-up	NA (NA)	0.1 (2.13)
Serum potassium, Day 3 (48 hour)	-0.03 (0.437)	-0.16 (0.517)
Serum potassium, Follow-up	NA (NA)	0.01 (0.446)
Serum sodium, Day 3 (48 hour)	-1.1 (1.45)	-0.9 (2.02)
Serum sodium, Follow-up	NA (NA)	0.4 (2.22)
Serum urea nitrogen, Day 3 (48 hour)	0.678 (0.8489)	1.321 (1.2692)
Serum urea nitrogen, Follow-up	NA (NA)	0.216 (1.7478)

81. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2
Description	Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Serum ALT, Day 3 (48 hour)	-0.2 (1.55)	1.3 (3.16)
Serum ALT, Follow-up	NA (NA)	3.1 (5.95)
Serum AP, Day 3 (48 hour)	-0.3 (5.44)	-0.3 (4.00)
Serum AP, Follow-up	NA (NA)	-1.7 (2.95)
Serum AST, Day 3 (48 hour)	0.5 (2.92)	1.0 (2.71)
Serum AST, Follow-up	NA (NA)	3.5 (4.81)
Serum CK, Day 3 (48 hour)	-22.7 (26.45)	-25.7 (15.81)
Serum CK, Follow-up	NA (NA)	-9.8 (13.99)

82. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2
Description	Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000mg (4 x 750 mg) RC tablets orally in Part 2 Period 2
Measure Participants	10	10
Serum albumin, Day 3 (48 hour)	-0.9 (3.38)	0.0 (1.70)
Serum albumin, Follow-up	NA (NA)	-1.5 (2.17)
Serum protein, Day 3 (48 hour)	0.0 (5.29)	-2.1 (4.63)
Serum protein, Follow-up,	NA (NA)	-1.8 (2.70)

83. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2
Description	Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin, serum creatinine and serum direct bilirubin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Serum bilirubin, Day 3 (48 hour)	-1.02 (2.944)	-3.62 (2.968)
Serum bilirubin	NA (NA)	-0.68 (4.207)
Serum creatinine, Day 3 (48 hour)	-1.76 (8.147)	-4.42 (6.254)
Serum creatinine	NA (NA)	-3.55 (7.458)
Serum direct bilirubin, Day 3 (48 hour)	-0.51 (1.147)	-1.02 (0.878)
Serum direct bilirubin, Follow-up	NA (NA)	-0.34 (1.075)

84. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter Serum Estradiol for Part 2
Description	Blood samples were collected for the assessment of chemistry parameter namely serum estradiol for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the indicated time point were analyzed. NA indicates standard deviation was not calculated as a single participant was analyzed.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	1	1
Mean (Standard Deviation) [picomoles/liter]	NA (NA)	0.00 (NA)

85. Secondary Outcome

Title	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2
Description	Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Blood basophils, Day 3 (48 hour)	0.002 (0.0092)	0.009 (0.0129)
Blood basophils, Follow-up	NA (NA)	0.004 (0.0097)
Blood eosinophils, Day 3 (48 hour)	0.036 (0.0626)	0.052 (0.0839)
Blood eosinophils, Follow-up	NA (NA)	0.021 (0.0671)
Blood leukocytes, Day 3 (48 hour)	0.129 (0.7779)	0.039 (0.8843)
Blood leukocytes, Follow-up	NA (NA)	-0.183 (0.7906)
Blood lymphocytes, Day 3 (48 hour)	0.222 (0.1707)	0.243 (0.2165)
Blood lymphocytes, Follow-up	NA (NA)	-0.038 (0.2875)
Blood monocytes, Day 3 (48 hour)	-0.020 (0.0651)	-0.013 (0.0732)
Blood monocytes, Follow-up	NA (NA)	0.045 (0.0546)
Blood neutrophils, Day 3 (48 hour)	-0.112 (0.6906)	-0.251 (0.6701)
Blood neutrophils, Follow-up	NA (NA)	-0.213 (0.8126)
Blood platelets, Day 3 (48 hour)	-7.4 (38.14)	-0.6 (33.37)
Blood platelets, Follow-up	NA (NA)	2.1 (31.49)

86. Secondary Outcome

Title	Change From Baseline in Hematology Parameters Ery. MCHC and Blood Hemoglobin for Part 2
Description	Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2
Measure Participants	10	10
Blood Ery. MCHC, Day 3 (48 hour)	-6.6 (4.35)	-6.6 (3.20)
Blood Ery. MCHC, Follow-up	NA (NA)	-6.2 (5.87)
Blood hemoglobin, Day 3 (48 hour)	2.8 (9.43)	0.9 (5.55)
Blood hemoglobin, Follow-up	NA (NA)	-5.9 (3.67)

87. Secondary Outcome

Title	Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 2
Description	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Blood Ery.MCH, Day 3 (48 hour)	-0.25 (0.331)	-0.06 (0.378)
Blood Ery. MCH, Follow-up	NA (NA)	-0.15 (0.488)

88. Secondary Outcome

Title	Change From Baseline in Hematology Parameter Blood Ery. MCV for Part 2
Description	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Blood Ery. MCV, Day 3 (48 hour)	1.17 (1.610)	1.69 (1.371)
Blood Ery. MCV, Follow-up	NA (NA)	1.28 (1.834)

89. Secondary Outcome

Title	Change From Baseline in Hematology Parameter Blood Ery. for Part 2
Description	Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Blood Ery., Day 3 (48 hour)	0.118 (0.2839)	0.033 (0.1675)
Blood Ery., Follow-up	NA (NA)	-0.175 (0.1099)

90. Secondary Outcome

Title	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2
Description	Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Blood hematocrit , Day 3 (48 hour)	1.6 (2.871)	1.02 (1.713)
Blood hematocrit, Follow-up	NA (NA)	-1.09 (1.079)

91. Secondary Outcome

Title	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2
Description	Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
SBP, Day 1 (2 hours)	-8.4 (15.78)	6.7 (10.49)
SBP, Day 2 (24 hours)	-9.6 (13.55)	-3.1 (12.90)
SBP, Day 3 (48 hours)	-4.1 (17.99)	-4.2 (11.03)
SBP, Follow-up	NA (NA)	-2.0 (17.81)
DBP, Day 1 (2 hours)	-6.7 (6.13)	-0.3 (6.95)
DBP, Day 2 (24 hours)	-5.4 (8.72)	-3.5 (6.92)
DBP, Day 3 (48 hours)	-1.9 (7.98)	-1.7 (6.62)
DBP, Follow-up	NA (NA)	-0.1 (11.35)

92. Secondary Outcome

Title	Change From Baseline in Vital Sign Parameter Heart Rate for Part 2
Description	Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Heart rate, Day 1 (2 hours)	0.1 (7.84)	3.2 (6.48)
Heart rate, Day 2 (24 hours)	-3.8 (12.38)	-1.4 (6.90)
Heart rate, Day 3 (48 hours)	-3.0 (11.22)	3.4 (6.29)
Heart rate, Follow-up	NA (NA)	-0.3 (9.06)

93. Secondary Outcome

Title	Change From Baseline in ECG Parameter Heart Rate for Part 2
Description	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
ECG Heart rate, Day 1 (2 hours)	5.4 (10.13)	4.9 (5.02)
ECG Heart rate, Day 2 (24 hours)	-1.2 (8.75)	-1.1 (6.71)
ECG Heart rate, Day 3 (48 hours)	2.1 (11.00)	3.4 (5.38)
ECG Heart rate, Follow-up	NA (NA)	-1.6 (8.18)

94. Secondary Outcome

Title	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2
Description	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 2. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2
Measure Participants	10	10
PR interval, Day 1 (2 hours)	-1.7 (13.92)	0.5 (11.49)
PR interval, Day 2 (24 hours)	7.2 (11.44)	-2.7 (7.23)
PR interval, Day 3 (48 hours)	5.1 (11.46)	3.0 (11.71)
PR interval, Follow-up	NA (NA)	-1.2 (15.37)
QRS duration, Day 1 (2 hours)	0.4 (5.19)	3.9 (4.28)
QRS duration, Day 2 (24 hours)	0.3 (4.57)	-0.2 (4.73)
QRS duration, Day 3 (48 hours)	-0.2 (4.54)	0.7 (4.06)
QRS duration, Follow-up	NA (NA)	1.6 (3.60)
QT interval Day 1 (2 hours)	-4.0 (16.21)	5.1 (16.04)
QT interval, Day 2 (24 hours)	4.8 (21.63)	11.7 (17.31)
QT interval, Day 3 (48 hours)	-1.0 (20.48)	-3.4 (14.95)
QT interval, Follow-up	NA (NA)	9.5 (17.37)
QTcB interval, Day 1 (2 hours)	15.2 (18.23)	20.7 (14.17)
QTcB, Day 2 (24 hours)	3.4 (11.64)	9.5 (8.24)
QTcB, Day 3 (48 hours)	6.6 (16.26)	6.0 (13.00)
QTcB, Follow-up	NA (NA)	5.7 (13.44)
QTcF interval, Day 1 (2 hours)	8.6 (9.56)	15.2 (13.09)
QTcF, Day 2 (24 hours)	4.0 (10.23)	10.4 (8.75)
QTcF, Day 3 (48 hours)	4.0 (8.60)	2.4 (11.64)
QTcF, Follow-up	NA (NA)	7.0 (9.36)

95. Secondary Outcome

Title	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2
Description	Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 4+ 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 2. Only categories with significant values have been presented.
Time Frame	Baseline and up to 11 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Tablets	Gepotidacin RC 3000 mg Tablets
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
Measure Participants	10	10
Urine Ketones, Follow-up, Trace	0 0%	1 10%
Urine Occult blood, Day 3 (48 hours), 1+	0 0%	1 10%
Urine Occult blood, Trace, Day 3 (48 hours),	2 7.7%	0 0%
Urine Occult blood, Follow-up, 1+	0 0%	1 10%
Urine pH, Day 3 (48 hours), 5+	2 7.7%	7 70%
Urine pH, Day 3 (48 hours), 6+	6 23.1%	2 20%
Urine pH, Day 3 (48 hours), 7+	1 3.8%	1 10%
Urine pH, Day 3 (48 hours), 8+	1 3.8%	0 0%
Urine pH, Follow-up, 5+	0 0%	3 30%
Urine pH, Follow-up, 6+	0 0%	6 60%
Urine pH, Follow-up, 8+	0 0%	1 10%
Urine Specific gravity, Day 3 (48 hours), 1+	10 38.5%	10 100%
Urine Specific gravity, Follow-up, 1+	0 0%	10 100%

96. Secondary Outcome

Title	Number of Participants With Non-serious AEs and SAEs for Part 3
Description	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
Time Frame	Up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed	Placebo
Arm/Group Description	Participants received a single dose gepotidacin 1500mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.	Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
Measure Participants	10	10	9	2
Non seriou AE	0 0%	1 10%	6 50%	0 0%
SAE	0 0%	0 0%	0 0%	0 0%

97. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3
Description	Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed	Placebo
Arm/Group Description	Participants received a single dose gepotidacin 1500mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.	Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
Measure Participants	10	10	9	2
Glucose,Period 1,Day 3(48 hour),n=10,0,0,2	0.038 (0.3178)	-0.305 (0.4313)
Glucose,Period 2,Day 3 (48 hour),n=0,10,0,2	-0.071 (0.2993)	-0.415 (0.2758)
Glucose,Period 3,Day 3 (48 hour),n=0,0,9,2	-0.197 (0.2355)	-0.335 (0.1626)
Glucose, Follow-up, n=0,0,9,2	-0.050 (0.2744)	-0.390 (0.3960)
Calcium,Period1, Day 3 (48 hour),n=10,0,0,2	-0.057 (0.0887)	-0.075 (0.1061)
Calcium,Period 2,Day 3 (48 hour),n=0,10,0,2	-0.046 (0.0819)	-0.115 (0.0919)
Calcium,Period 3,Day 3 (48 hour),n=0,0,9,2	-0.028 (0.0502)	-0.105 (0.0354)
Calcium, Follow-up, n=0,0, 9, 2	-0.039 (0.0742)	-0.040 (0.0141)
Carbon dioxide,Period 1,Day 3(48 hour),n=10,0,0,2	-0.6 (1.51)	0.5 (0.71)
Carbon dioxide,Period 2,Day 3(48 hour),n=0,10,0,2	-0.7 (1.64)	2.5 (2.12)
Carbon dioxide,Period 3,Day 3(48 hour),n=0,0,9,2	-1.1 (1.36)	1.5 (0.71)
Carbon dioxide, Follow-up, n=0,0,9,2	0.2 (2.28)	1.5 (0.71)
Chloride, Period 1, Day 3 (48 hour),n=10,0,0,2	0.8 (1.23)	1.0 (2.83)
Chloride, Period 2, Day 3 (48 hour),n=0,10,0,2	0.8 (1.75)	-2.0 (0.00)
Chloride, Period 3, Day 3 (48 hour),n=0,0,9,2	0.1 (1.96)	-1.5 (0.71)
Chloride, Follow-up,n=0,0,9,2	0.2 (2.95)	-2.0 (0.00)
Potassium, Period 1, Day 3 (48 hour), n=10,0,0,2	-0.21 (0.536)	-0.10 (0.283)
Potassium, Period 2, Day 3 (48 hour), n=0,10,0,2	-0.19 (0.381)	-0.40 (1.131)
Potassium, Period 3, Day 3 (48 hour), n=0,0,9,2	-0.28 (0.561)	-0.30 (1.273)
Potassium, Follow-up, n=0,0,9,2	-0.21 (0.359)	-0.15 (0.919)
Sodium, Period 1, Day 3 (48 hour), n=10,0,0,2	0.6 (2.12)	2.5 (2.12)
Sodium, Period 2, Day 3 (48 hour), n=0,10,0,2	0.1 (2.38)	-1.0 (2.83)
Sodium, Period 3, Day 3 (48 hour), n=0,0,9,2	0.3 (1.94)	-2.0 (4.24)
Sodium, Follow-up, n=0,0,9,2	-0.1 (1.90)	-2.5 (2.12)
Urea nitrogen,Period 1,Day 3 (48 hour),n=10,0,0,2	0.606 (1.0760)	0.535 (0.2475)
Urea nitrogen,Period 2,Day 3 (48 hour),n=0,10,0,2	0.677 (1.3401)	1.610 (0.7637)
Urea nitrogen,Period 3,Day 3 (48 hour),n=0,0,9,2	0.474 (1.4617)	1.075 (0.0071)
Urea nitrogen, Follow-up, n=0,0,9,2	0.356 (1.2998)	2.320 (2.7860)

98. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3
Description	Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed	Placebo
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.	Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
Measure Participants	10	10	9	2
ALT, Period 1, Day 3 (48 hour), n=10,0,0,2	0.1 (2.73)	-2.5 (2.12)
ALT, Period 2, Day 3 (48 hour), n=0,10,0,2	2.2 (3.36)	-4.0 (7.07)
ALT, Period 3, Day 3 (48 hour), n=0,0,9,2,	6.0 (3.74)	-4.5 (9.19)
ALT, Follow-up, n=0,0,9,2	5.9 (4.11)	-5.0 (11.31)
AP, Period 1, Day 3 (48 hour), n=10,0,0,2,	-3.6 (2.07)	-9.0 (5.66)
AP, Period 2, Day 3 (48 hour), n=0,10,0,2	-2.5 (4.62)	-2.0 (4.24)
Serum AP, Day 3 (48 hour), n=0,0,9,2	0.6 (3.88)	-0.5 (0.71)
AP, Follow-up, n=0,0,9,2	1.8 (3.96)	3.5 (3.54)
AST, Period 1, Day 3 (48 hour),n=10,0,0,2	1.3 (3.06)	-3.5 (2.12)
AST, Period 2, Day 3 (48 hour),n=0,10,0,2	1.7 (2.50)	-5.0 (4.24)
AST, Period 3, Day 3 (48 hour),n=0,0,9,2	4.2 (2.68)	-5.0 (5.66)
AST, Follow-up, n=0,0,9,2	2.6 (2.46)	-4.0 (7.07)
CK, Period 1, Day 3 (48 hour),n=10,0,0,2	-28.1 (17.60)	-22.5 (14.85)
CK, Period 2, Day 3 (48 hour),n=0,10,0,2	-11.8 (65.84)	-33.5 (23.33)
CK, Period 3, Day 3 (48 hour),n=0,0,9,2	-14.3 (20.27)	-21.5 (9.19)
CK, Follow-up, n=0,0,9,2	3.7 (26.87)	1.0 (11.31)

99. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3
Description	Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed	Placebo
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.	Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
Measure Participants	10	10	9	2
Albumin, Part 1, Day 3 (48 hour), n=10,0,0,2	-2.0 (2.54)	-2.0 (0.00)
Albumin, Period 2, Day 3 (48 hour), n=0,10,0,2	-2.0 (1.05)	-3.0 (1.41)
Albumin, Period 3, Day 3 (48 hour), n=0,0,9,2	-0.6 (3.05)	-2.5 (0.71)
Albumin, Follow-up, n=0,0,9,2	-0.3 (3.12)	-0.5 (2.12)
Protein, Period 1, Day 3 (48 hour), n=10,0,0,2	-3.0 (2.31)	-4.5 (0.71)
Protein, Period 2, Day 3 (48 hour), n=0,10,0,2	-2.2 (3.01)	-5.0 (1.41)
Protein, Period 3, Day 3 (48 hour), n=0,0,9,2	-0.6 (3.97)	-4.5 (0.71)
Protein, Follow-up, n=0,0,9,2	-0.6 (4.64)	-1.0 (5.66)

100. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3
Description	Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin and serum creatinine for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed	Placebo
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.	Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
Measure Participants	10	10	9	2
Bilirubin, Period 1, Day 3 (48 hour), n=10,0,0,2	-2.43 (3.364)	-0.85 (1.202)
Bilirubin, Period 2, Day 3 (48 hour), n=0,10,0,2,	-3.11 (3.793)	-1.70 (0.000)
Bilirubin, Period 3, Day 3 (48 hour), n=0,0,9,2	-2.28 (3.844)	0.85 (1.202)
Bilirubin, Follow-up, n=0,0,9,2	-1.53 (2.757)	-1.70 (0.000)
Creatinine, Period 1,Day 3 (48 hour), n=10,0,0,2	-1.75 (8.101)	-17.65 (12.516)
Creatinine, Period 2,Day 3 (48 hour), n=0,10,0,2	-1.75 (6.958)	-17.60 (0.000)
Creatinine, Period 3,Day 3 (48 hour), n=0,0,9,2	0.01 (7.636)	-13.20 (6.223)
Creatinine, Follow-up, n=0,0,9,2	2.97 (6.258)	-4.40 (6.223)

101. Secondary Outcome

Title	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3
Description	Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed	Placebo
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.	Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
Measure Participants	10	10	9	2
Basophils, Period 1, Day 3 (48 hour), n=10,0,0,2	0.004 (0.0158)	0.000 (0.0141)
Basophils, Period 2, Day 3 (48 hour), n=0,10,0,2,	0.009 (0.0120)	-0.010 (0.0141)
Basophils, Period 3, Day 3 (48 hour), n=0,0,9,2	0.009 (0.0162)	0.005 (0.0071)
Basophils, Follow-up, n=0,0,9,2	0.008 (0.0186)	0.015 (0.0071)
Eosinophils, Period 1, Day 3 (48 hour),n=10,0,0,2	0.053 (0.0254)	0.060 (0.0707)
Eosinophils, Period 2,Day 3 (48 hour), n=0,10,0,2	0.068 (0.0421)	0.055 (0.0778)
Eosinophils, Period 3,Day 3 (48 hour), n=0,0,9,2	0.053 (0.0487)	0.040 (0.0990)
Eosinophils, Follow-up, n=0,0,9,2	0.022 (0.0192)	0.045 (0.1061)
Leukocytes, Period 1, Day 3 (48 hour),n=10,0,0,2	0.581 (0.6524)	-1.000 (0.8202)
Leukocytes, Period 2, Day 3 (48 hour),n=0,10,0,2	0.730 (0.8427)	-1.415 (1.0819)
Leukocytes, Period 3, Day 3 (48 hour),n=0,0,9,2	0.966 (0.7001)	-1.670 (0.9475)
Leukocytes, Follow-up, n=0,0,9,2	0.132 (0.8490)	-1.630 (0.2121)
Lymphocytes, Period 1,Day 3 (48 hour),n=10,0,0,2	0.209 (0.2885)	0.060 (0.2263)
Lymphocytes, Period 2,Day 3 (48 hour),n=0,10,0,2	0.144 (0.3405)	-0.035 (0.2192)
Lymphocytes, Period 3,Day 3 (48 hour),n=0,0,9,2	-0.009 (0.3207)	-0.100 (0.2404)
Lymphocytes, Follow-up, n=0,0, 9, 2	-0.089 (0.1928)	-0.050 (0.0283)
Monocytes, Period 1, Day 3 (48 hour),n=10,0,0,2,	0.022 (0.0598)	-0.025 (0.0354)
Monocytes, Period 2, Day 3 (48 hour),n=0,10,0,2	0.010 (0.0615)	-0.080 (0.0424)
Monocytes, Period 3, Day 3 (48 hour),n=0,0,9,2	0.042 (0.0427)	-0.110 (0.0000)
Monocytes, Follow-up, n=0,0,9,2	-0.002 (0.0452)	-0.100 (0.0424)
Neutrophils, Period 1,Day 3 (48 hour),n=10,0,0,2	0.292 (0.8198)	-1.100 (1.1597)
Neutrophils, Period 2,Day 3 (48 hour),n=0,10,0,2	0.489 (0.7302)	-1.350 (0.8910)
Neutrophils, Period 3,Day 3 (48 hour),n=0,0,9,2	0.850 (0.8456)	-1.505 (0.7990)
Neutrophils, Follow-up, n=0,0,9,2	0.184 (0.8251)	-1.545 (0.3606)
Platelets, Period 1, Day 3 (48 hour),n=10,0,0,2	-4.7 (13.19)	-10.5 (10.61)
Platelets, Period 2, Day 3 (48 hour),n=0,10,0,2	-22.2 (41.82)	-5.0 (5.66)
Platelets, Period 3, Day 3 (48 hour),n=0,0,9,2	-6.0 (19.80)	-15.0 (8.49)
Platelets, Follow-up, n=0,0,9,2	2.4 (21.93)	4.0 (8.49)

102. Secondary Outcome

Title	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3
Description	Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed	Placebo
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.	Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
Measure Participants	10	10	9	2
Ery. MCHC, Period 1, Day 3 (48 hour), n=10,0,0,2	-2.9 (5.67)	-2.0 (9.90)
Ery. MCHC, Period 2, Day 3 (48 hour), n=0,10,0,2	-3.2 (3.49)	-1.5 (4.95)
Ery. MCHC, Period 3, Day 3 (48 hour), n=0,0,9,2	-5.3 (5.22)	-6.5 (2.12)
Ery. MCHC, Follow-up, n=0,0,9,2	-1.2 (4.94)	0.0 (0.00)
Hemoglobin, Period 1,Day 3 (48 hour), n=10,0,0,2	-1.4 (6.70)	-7.5 (0.71)
Hemoglobin, Period 2, Day 3 (48 hour), n=0,10,0,2	-3.4 (9.35)	-11.5 (0.71)
Hemoglobin, Period 3,Day 3 (48 hour), n=0,0,9,2	-2.1 (6.47)	-10.5 (0.71)
Hemoglobin, Follow-up, n=0,0,9,2	-6.0 (7.62)	-6.5 (7.78)

103. Secondary Outcome

Title	Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 3
Description	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed	Placebo
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.	Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
Measure Participants	10	10	9	2
Ery.MCH, Period 1, Day 3 (48 hour), n=10,0,0,2	0.08 (0.397)	0.25 (0.071)
Ery.MCH, Period 2, Day 3 (48 hour), n=0,10,0,2	0.08 (0.270)	0.15 (0.212)
Ery.MCH, Period 3 Day 3 (48 hour), n=0,0,9,2	-0.12 (0.380)	0.00 (0.283)
Ery. MCH, Follow-up, n=0,0,9,2	0.31 (0.483)	0.00 (0.424)

104. Secondary Outcome

Title	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 3
Description	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed	Placebo
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.	Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
Measure Participants	10	10	9	2
Ery. MCV, Period 1, Day 3 (48 hour), n=10,0,0,2	1.10 (1.152)	1.30 (2.970)
Ery. MCV, Period 2, Day 3 (48 hour), n=0,10,0,2	1.14 (0.857)	0.70 (2.121)
Ery. MCV, Period 3, Day 3 (48 hour), n=0,0,9,2	1.16 (1.167)	1.80 (0.000)
Ery. MCV, Follow-up, n=0,0,9,2	1.31 (1.430)	0.00 (1.131)

105. Secondary Outcome

Title	Change From Baseline in Hematology Parameter Blood Ery. for Part 3
Description	Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed	Placebo
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.	Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
Measure Participants	10	10	9	2
Ery., Period 1, Day 3 (48 hour), n=10,0,0,2	-0.065 (0.2576)	-0.275 (0.0354)
Ery.,Period 2, Day 3 (48 hour), n=0,10,0,2	-0.138 (0.3381)	-0.390 (0.0566)
Ery., Period 3, Day 3 (48 hour), n=0,0,9,2	-0.060 (0.2536)	-0.340 (0.0566)
Ery., Follow-up, n=0,0,9,2	-0.253 (0.3347)	-0.210 (0.3111)

106. Secondary Outcome

Title	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 3
Description	Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed	Placebo
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.	Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
Measure Participants	10	10	9	2
Hematocrit, Period 1,Day 3 (48 hour), n=10,0,0,2	-0.02 (2.170)	-2 (0.990)
Hematocrit, Period 2,Day 3 (48 hour), n=0,10,0,2	-0.65 (2.991)	-3.3 (0.424)
Hematocrit, Period 3,Day 3 (48 hour), n=0,0,9,2	0.02 (2.299)	-2.35 (0.495)
Hematocrit, Follow-up, n=0,0,9,2	-1.67 (2.545)	-1.95 (2.333)

107. Secondary Outcome

Title	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3
Description	Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed	Placebo
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.	Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
Measure Participants	10	10	9	2
SBP, Period 1, Day 1 (2 hours), n=10,0,0,2	4.6 (10.94)	6.0 (7.07)
SBP, Period 1, Day 2 (24 hours), n=10,0,0,2	-4.3 (11.13)	0.5 (3.54)
SBP, Period 1, Day 3 (48 hours), n=10,0,0,2	-4.8 (8.63)	-1.5 (0.71)
SBP, Period 2, Day 1 (2 hours), n=0,10,0,2	3.5 (11.18)	10.5 (6.36)
SBP, Period 2, Day 2 (24 hours), n=0,10,0,2	-2.0 (9.71)	6.0 (7.07)
SBP, Period 2, Day 3 (48 hours), n=0,10,0,2	1.2 (9.37)	-3.5 (4.95)
SBP, Period 3, Day 1 (2 hours), n=0,0,9,2	7.4 (12.89)	-1.0 (1.41)
SBP, Period 3, Day 2 (24 hours), n=0,0,9,2	4.1 (8.19)	-0.5 (2.12)
SBP, Period 3, Day 3 (48 hours), n=0,0,9,2	-0.7 (10.65)	0.0 (12.73)
SBP, Follow-up, n=0,0,9,2	5.1 (7.42)	-4.5 (3.54)
DBP, Period 1, Day 1 (2 hours), n=10,0,0,2	3.4 (9.63)	5.0 (8.49)
DBP, Period 1, Day 2 (24 hours), n=10,0,0,2	-4.4 (7.56)	0.0 (7.07)
DBP, Period 1, Day 3 (48 hours), n=10,0,0,2	-3.7 (7.73)	2.0 (2.83)
DBP, Period 2, Day 1 (2 hours), n=0,10,0,2	-3.4 (7.73)	-4.5 (0.71)
DBP, Period 2, Day 2 (24 hours), n=0,10,0,2	-2.6 (8.97)	-4.0 (0.00)
DBP, Period 2, Day 3 (48 hours), n=0,10,0,2	0.7 (8.81)	-4.5 (0.71)
DBP, Period 3, Day 1 (2 hours), n=0,0,9,2	-2.8 (13.58)	4.0 (9.90)
DBP, Period 3, Day 2 (24 hours), n=0,0,9,2	-3.2 (3.96)	4.0 (0.00)
DBP, Period 3, Day 3 (48 hours), n=0,0,9,2	-1.3 (9.34)	3.0 (5.66)
DBP, Follow-up, n=0,0,9,2	2.2 (9.80)	2.5 (3.54)

108. Secondary Outcome

Title	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3
Description	Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed	Placebo
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.	Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
Measure Participants	10	10	9	2
Heart rate, Period 1, Day 1 (2 hours), n=10,0,0,2	1.6 (8.88)	1.0 (15.56)
Heart rate, Period 2, Day 2 (24 hours), n=10,0,0,2	0.1 (7.37)	-4.5 (16.26)
Heart rate, Period 1, Day 3 (48 hours), n=10,0,0,2	-3.2 (8.27)	-4.0 (15.56)
Heart rate, Period 2, Day 1 (2 hours), n=0,10,0,2	4.9 (6.47)	5.0 (8.49)
Heart rate, Period 2, Day 2 (24 hours), n=0,10,0,2	0.9 (4.89)	2.0 (7.07)
Heart rate, Period 2, Day 3 (48 hours), n=0,10,0,2	3.0 (4.35)	-2.5 (0.71)
Heart rate, Period 3, Day 1 (2 hours), n=0,0,9,2	4.6 (7.65)	7.0 (11.31)
Heart rate, Period 3, Day 2 (24 hours), n=0,0,9,2	1.1 (6.27)	0.5 (3.54)
Heart rate, Period 3, Day 3 (48 hours), n=0,0,9,2	3.2 (9.92)	6.5 (12.02)
Heart rate, Follow-up, n=0,0,9,2	-4.2 (8.83)	0.5 (0.71)

109. Secondary Outcome

Title	Change From Baseline in ECG Parameter Heart Rate for Part 3
Description	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed	Placebo
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.	Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
Measure Participants	10	10	9	2
ECG Heart rate,Period1,Day 1 (2 hours),n=10,0,0,2	8.0 (7.15)	5.0 (8.49)
ECG Heart rate,Period1,Day 2 (24 hours),n=10,0,0,2	-0.3 (4.11)	-4.0 (4.24)
ECG Heart rate,Period1,Day 3 (48 hours),n=10,0,0,2	4.8 (6.75)	0.0 (9.90)
ECG Heart rate,Period2,Day 1 (2 hours),n=0,10,0,2	6.4 (8.88)	10.0 (7.07)
ECG Heart rate,Period2,Day 2 (24 hours),n=0,10,0,2	-0.2 (8.78)	8.0 (8.49)
ECG Heart rate,Period2,Day 3 (48 hours),n=0,10,0,2	-0.5 (10.32)	3.0 (5.66)
ECG Heart rate,Period3,Day 1 (2 hours),n=0,0,9,2	8.0 (7.04)	5.5 (6.36)
ECG Heart rate,Period3,Day 2 (24 hours),n=0,0,9,2	4.6 (13.61)	12.0 (15.56)
ECG Heart rate,Period3,Day 3 (48 hours),n=0,0,9,2	1.4 (5.98)	5.0 (9.90)
ECG Heart rate, Follow-up, n=0,0,9,2	-3.8 (6.72)	-1.0 (0.00)

110. Secondary Outcome

Title	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3
Description	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 3. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Time Frame	Baseline and up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed	Placebo
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.	Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
Measure Participants	10	10	9	2
PR interval, Period1,Day 1 (2 hours),n=10,0,0,2	-3.3 (12.58)	-1.0 (5.66)
PR interval, Period1,Day 2 (24 hours),n=10,0,0,2	-1.9 (7.82)	-1.0 (5.66)
PR interval,Period1,Day 3 (48 hours), n=10,0,0,2	-3.7 (9.08)	0.0 (4.24)
PR interval,Period 2,Day 1 (2 hours),n=0,10,0,2	-7.5 (12.70)	-8.5 (0.71)
PR interval,Period 2, Day 2 (24 hours),n=0,10,0,2	-2.2 (9.02)	1.0 (4.24)
PR interval, Period2, Day 3 (48 hours),n=0,10,0,2	-3.5 (13.92)	3.0 (1.41)
PR interval,Period 3,Day 1 (2 hours),n=0,0,9,2	-0.1 (6.77)	-4.0 (14.14)
PR interval,Period 3,Day 2 (24 hours),n=0,0,9,2	4.8 (13.94)	0.5 (7.78)
PR interval,Period 3,Day 3 (48 hours), n=0,0,9,2	0.3 (16.18)	4.0 (16.97)
PR interval, Follow-up, n=0,0,9,2	6.1 (11.95)	-6.0 (24.04)
QRS duration,Period 1,Day 1 (2 hours),n=10,0,0,2	2.0 (10.73)	3.5 (9.19)
QRS duration,Period 1,Day 2 (24 hours),n=10,0,0,2	4.3 (8.63)	-3.0 (7.07)
QRS duration,Period 1,Day 3 (48 hours),n=10,0,0,2	0.5 (10.50)	2.0 (4.24)
QRS duration,Period 2,Day 1 (2 hours),n=0,10,0,2	1.8 (4.71)	2.0 (7.07)
QRS duration,Period 2, Day 2 (24 hours),n=0,10,0,2	0.4 (7.07)	-2.5 (19.09)
QRS duration,Period 2, Day 3 (48 hours),n=0,10,0,2	-1.1 (6.40)	1.5 (3.54)
QRS duration,Period 3,Day 1(2 hours),n=0,0,9,2	2.9 (4.65)	1.5 (4.95)
QRS duration,Period 3,Day 2(24 hours),n=0,0,9,2	-2.6 (4.39)	8.0 (8.49)
QRS duration,Period3, Day 3(48 hours),n=0,0,9,2	-1.1 (8.74)	3.5 (14.85)
QRS duration, Follow-up, n=0,0,9,2	-0.7 (6.52)	4.5 (7.78)
QT interval,Period 1, Day 1(2 hours),n=10,0,0,2	-9.2 (19.47)	-15.0 (19.80)
QT interval,Period 1,Day 2(24 hours),n=10,0,0,2	7.9 (19.45)	-6.0 (24.04)
QT interval,Period 1, Day 3(48 hours),n=10,0,0,2	0.4 (22.89)	-0.5 (12.02)
QT interval,Period 2, Day 1 (2 hours),n=0,10,0,2	-4.0 (22.45)	-14.5 (23.33)
QT interval,Period 2, Day 2 (24 hours),n=0,10,0,2	3.7 (15.93)	-12.5 (31.82)
QT interval,Period 2, Day 3 (48 hours),n=0,10,0,2	0.0 (26.86)	-3.0 (2.83)
QT interval,Period 3, Day 1 (2 hours),n=0,0,9,2	-7.9 (11.61)	-12.5 (31.82)
QT interval,Period 3, Day 2 (24 hours),n=0,0,9,2	-6.2 (24.03)	-15.0 (28.28)
QT interval,Period 3, Day 3 (48 hours),n=0,0,9,2	-3.0 (15.28)	-15.0 (36.77)
QT interval, Follow-up, n=0,0,9,2	11.4 (17.84)	8.5 (6.36)
QTcB ,Period 1, Day 1 (2 hours), n=10,0,0,2	16.4 (25.48)	-1.0 (2.83)
QTcB, Period 1, Day 2 (24 hours), n=10,0,0,2	8.6 (16.10)	-19.5 (9.19)
QTcB, Period 1, Day 3 (48 hours), n=10,0,0,2	15.7 (14.70)	-1.0 (19.80)
QTcB, Period 2, Day 1 (2 hours), n=0,10,0,2	15.1 (20.18)	15.0 (8.49)
QTcB, Period 2, Day 2 (24 hours), n=0,10,0,2	5.1 (13.98)	9.5 (12.02)
QTcB, Period 2, Day 3 (48 hours), n=0,10,0,2	1.8 (12.99)	5.5 (13.44)
QTcB, Period 3, Day 1 (2 hours), n=0,0,9,2	14.9 (21.83)	4.0 (14.14)
QTcB, Period 3, Day 2 (24 hours), n=0,0,9,2	5.8 (11.14)	18.5 (12.02)
QTcB, Period 3, Day 3 (48 hours), n=0,0,9,2	2.1 (10.02)	-3.0 (8.49)
QTcB, Follow-up, n=0,0,9,2	1.9 (14.88)	6.5 (6.36)
QTcF, Period 1, Day 1 (2 hours), n=10,0,0,2	7.7 (20.94)	-6.0 (5.66)
QTcF, Period 1, Day 2 (24 hours), n=10,0,0,2	8.3 (16.09)	-15.0 (14.14)
QTcF, Period 1, Day 3 (48 hours), n=10,0,0,2	10.5 (14.75)	-1.0 (8.49)
QTcF, Period 2, Day 1 (2 hours), n=0,10,0,2	8.4 (17.65)	5.0 (14.14)
QTcF, Period 2, Day 2 (24 hours), n=0,10,0,2	4.5 (7.09)	2.5 (19.09)
QTcF, Period 2, Day 3 (48 hours), n=0,10,0,2	1.2 (10.25)	2.5 (7.78)
QTcF, Period 3, Day 1 (2 hours), n=0,0,9,2	6.8 (16.15)	-1.5 (20.51)
QTcF, Period 3, Day 2 (24 hours), n=0,0,9,2	1.2 (4.99)	7.0 (2.83)
QTcF, Period 3, Day 3 (48 hours), n=0,0,9,2	0.2 (9.18)	-7.0 (18.38)
QTcF, Follow-up, n=0,0,9,2	5.2 (13.55)	7.0 (7.07)

111. Secondary Outcome

Title	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3
Description	Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 3. Only categories with significant values have been presented.
Time Frame	Up to 14 days

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Gepotidacin RC 1500 mg Fed	Gepotidacin RC 2250 mg Fed	Gepotidacin RC 3000 mg Fed	Placebo
Arm/Group Description	Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.	Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.	Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.	Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
Measure Participants	10	10	9	2
Urine Ketones, Follow-up, 1+	0 0%	0 0%	1 8.3%	0 0%
Urine Occult blood,Trace,Period 1, Day 3 (48hours)	2 7.7%	0 0%	0 0%	0 0%
Urine Occult blood,Period 1,Day 3 (48hours), 1+	0 0%	0 0%	0 0%	1 2.1%
Urine Occult blood,Period 1,Day 3 (48hours), 3+	1 3.8%	0 0%	0 0%	0 0%
Urine Occult blood,Trace,Period 2,Day 3 (48hours)	0 0%	1 10%	0 0%	0 0%
Urine Occult blood,Period 2,Day 3 (48hours), 1+	0 0%	1 10%	0 0%	0 0%
Urine Occult blood,Trace,Period 3,Day 3 (48hours)	0 0%	0 0%	2 16.7%	0 0%
Urine Occult blood,Period 3,Day 3 (48hours), 1+	0 0%	0 0%	1 8.3%	0 0%
Urine Occult blood, Follow-up, 4+	0 0%	0 0%	1 8.3%	0 0%
Urine pH, Period 1 Day 3 (48 hours), 5+	0 0%	0 0%	0 0%	1 2.1%
Urine pH, Period 1, Day 3 (48 hours), 6+	4 15.4%	0 0%	0 0%	1 2.1%
Urine pH, Period 1, Day 3 (48 hours), 7+	5 19.2%	0 0%	0 0%	1 2.1%
Urine pH, Period 1, Day 3 (48 hours), 8+	1 3.8%	0 0%	0 0%	0 0%
Urine pH, Period 2, Day 3 (48 hours), 5+	0 0%	6 60%	0 0%	2 4.2%
Urine pH, Period 2, Day 3 (48 hours), 6+	0 0%	2 20%	0 0%	0 0%
Urine pH, Period 2, Day 3 (48 hours), 7+	0 0%	2 20%	0 0%	0 0%
Urine pH, Period 3, Day 3 (48 hours), 5+	0 0%	0 0%	3 25%	0 0%
Urine pH, Period 3, Day 3 (48 hours), 6+	0 0%	0 0%	5 41.7%	2 4.2%
Urine pH, Period 3, Day 3 (48 hours), 7+	0 0%	0 0%	1 8.3%	0 0%
Urine pH, Follow-up, 5+	0 0%	0 0%	3 25%	1 2.1%
Urine pH, Follow-up, 6+	0 0%	0 0%	2 16.7%	1 2.1%
Urine pH, Follow-up, 7+	0 0%	0 0%	4 33.3%	0 0%
Urine Specific gravity, Period1,Day 3(48 hours),1+	10 38.5%	0 0%	0 0%	2 4.2%
Urine Specific gravity, Period2,Day 3(48 hours),1+	0 0%	10 100%	0 0%	2 4.2%
Urine Specific gravity,Period 3,Day 3(48 hours),1+	0 0%	0 0%	9 75%	2 4.2%
Urine Specific gravity, Follow-up, 1+	0 0%	0 0%	9 75%	2 4.2%

Adverse Events

	Gepotidacin 1500 mg - R Capsules		Gepotidacin 1500 mg RC Tablets		Gepotidacin 1500 mg HSWG Tablets		Gepotidacin RC 1500 mg Tablets		Gepotidacin RC 3000 mg Tablets		Gepotidacin RC 1500 mg Fed		Gepotidacin RC 2250 mg Fed		Gepotidacin RC 3000 mg Fed		Placebo
Time Frame	Non-serious AEs and SAEs were collected from Day 1 until follow-up (Up to 14 days in Part 1a, 11 days in Part 1b and 2 and 14 days in Part 3).
Adverse Event Reporting Description	Safety population was used to assess non-serious AEs and SAEs.

Arm/Group Title	Gepotidacin 1500 mg - R Capsules		Gepotidacin 1500 mg RC Tablets		Gepotidacin 1500 mg HSWG Tablets		Gepotidacin RC 1500 mg Tablets		Gepotidacin RC 3000 mg Tablets		Gepotidacin RC 1500 mg Fed		Gepotidacin RC 2250 mg Fed		Gepotidacin RC 3000 mg Fed		Placebo
Arm/Group Description	Participants received gepotidacin 1500 mg (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.		Participants received gepotidacin 1500 mg (2 x 750) RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.		Participants received gepotidacin 1500 mg (2 x 750) HSWG tablets orally in one of the three treatment periods in Part 1a.		Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.		Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.		Participants received gepotidacin 1500 mg (2 x 750) RC tablets in the fed state orally in one of the 3 treatment periods for 3 days in Part 3.		Participants received gepotidacin 1500 mg (2 x 750) RC tablets in the fed state orally in one of the 3 treatment periods for 3 days in Part 3.		Participants received gepotidacin 3000 mg (4 x 750) RC tablets in the fed state in one of the 3 treatment periods in Part 3.		Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)		0/26 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/9 (0%)		0/2 (0%)
Serious Adverse Events
	Gepotidacin 1500 mg - R Capsules		Gepotidacin 1500 mg RC Tablets		Gepotidacin 1500 mg HSWG Tablets		Gepotidacin RC 1500 mg Tablets		Gepotidacin RC 3000 mg Tablets		Gepotidacin RC 1500 mg Fed		Gepotidacin RC 2250 mg Fed		Gepotidacin RC 3000 mg Fed		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)		0/26 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/9 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Gepotidacin 1500 mg - R Capsules		Gepotidacin 1500 mg RC Tablets		Gepotidacin 1500 mg HSWG Tablets		Gepotidacin RC 1500 mg Tablets		Gepotidacin RC 3000 mg Tablets		Gepotidacin RC 1500 mg Fed		Gepotidacin RC 2250 mg Fed		Gepotidacin RC 3000 mg Fed		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/26 (30.8%)		5/26 (19.2%)		9/26 (34.6%)		6/10 (60%)		9/10 (90%)		0/10 (0%)		1/10 (10%)		6/9 (66.7%)		0/2 (0%)
Gastrointestinal disorders
Diarrhoea	6/26 (23.1%)		5/26 (19.2%)		6/26 (23.1%)		5/10 (50%)		9/10 (90%)		0/10 (0%)		0/10 (0%)		1/9 (11.1%)		0/2 (0%)
Abdominal pain	2/26 (7.7%)		2/26 (7.7%)		5/26 (19.2%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/9 (0%)		0/2 (0%)
Nausea	1/26 (3.8%)		1/26 (3.8%)		2/26 (7.7%)		0/10 (0%)		6/10 (60%)		0/10 (0%)		0/10 (0%)		4/9 (44.4%)		0/2 (0%)
Flatulence	1/26 (3.8%)		2/26 (7.7%)		0/26 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/9 (0%)		0/2 (0%)
Abdominal pain upper	0/26 (0%)		0/26 (0%)		0/26 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/9 (0%)		0/2 (0%)
Paraesthesia oral	0/26 (0%)		0/26 (0%)		0/26 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/9 (0%)		0/2 (0%)
Salivary hypersecretion	0/26 (0%)		0/26 (0%)		0/26 (0%)		1/10 (10%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/9 (0%)		0/2 (0%)
Vomiting	0/26 (0%)		0/26 (0%)		0/26 (0%)		0/10 (0%)		5/10 (50%)		0/10 (0%)		0/10 (0%)		1/9 (11.1%)		0/2 (0%)
Abdominal discomfort	0/26 (0%)		0/26 (0%)		0/26 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		2/9 (22.2%)		0/2 (0%)
Faeces soft	0/26 (0%)		0/26 (0%)		0/26 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		2/9 (22.2%)		0/2 (0%)
Nervous system disorders
Dizziness	1/26 (3.8%)		0/26 (0%)		0/26 (0%)		1/10 (10%)		4/10 (40%)		0/10 (0%)		0/10 (0%)		1/9 (11.1%)		0/2 (0%)
Headache	0/26 (0%)		0/26 (0%)		1/26 (3.8%)		2/10 (20%)		3/10 (30%)		0/10 (0%)		0/10 (0%)		2/9 (22.2%)		0/2 (0%)
Muscle contractions involuntary	0/26 (0%)		0/26 (0%)		0/26 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/9 (0%)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

Name/Title	GSK Response Center
Organization	GlaxoSmithKline
Phone	866-435-7343
Email	GSKClinicalSupportHD@gsk.com

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT02853435

Other Study ID Numbers:

117351

First Posted:

Aug 3, 2016

Last Update Posted:

Oct 8, 2020

Last Verified:

Sep 1, 2020