A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04128293
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 4
• Actual Duration (Months): 1.2
• Patients Per Site Per Month: 12.8

Study Details

Study Description

Brief Summary

This is an open-label, single-dose, four-period, four sequential, and crossover study conducted to assess the relative bioavailability of GSK3640254 mesylate tablets and GSK3640254 mesylate capsules (in the presence of a moderate fat meal). This study will also evaluate the effect of food (fasted, moderate fat meal, and high fat meal) on the pharmacokinetics of GSK3640254 mesylate tablet formulation. Participants will be randomized to receive a single dose of GSK3640254 200 milligram (mg) capsules under moderate fat conditions and GSK3640254 200 mg tablets under moderate fat, fasted and high fat conditions in each treatment period. Approximately 16 participants will be enrolled and the duration of the study will be approximately 54 days.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: GSK3640254 Tablet; Drug: GSK3640254 Capsule	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Eligible participants will be randomly assigned to 1 of 4 treatment sequences (ABCD, BADC, CDAB, or DCBA) in each treatment period.Eligible participants will be randomly assigned to 1 of 4 treatment sequences (ABCD, BADC, CDAB, or DCBA) in each treatment period.
• Masking: None (Open Label)
• Masking Description: This is an open-label study.
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-Label, Single Dose, Four-Period Crossover Clinical Trial to Assess the Relative Bioavailability of a Tablet Compared to a Capsule of GSK3640254 and to Assess the Effect of Food on the GSK3640254 Tablet in Healthy Participants
• Actual Study Start Date: Oct 8, 2019
• Actual Primary Completion Date: Nov 15, 2019
• Actual Study Completion Date: Nov 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 - Treatment ABCD Participants will receive a single dose of GSK3640254 200 mg (Treatment A- Reference), capsules, orally under moderate fat conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment B- Test), tablets, orally under moderate fat conditions on Day 1 in second intervention period; followed by GSK3640254 200 mg (Treatment C- Reference), tablets, orally under fasted conditions on Day 1 in third intervention period; further followed by GSK3640254 200 mg (Treatment D- Test), tablets, orally under high fat conditions on Day 1 in fourth intervention period. There will be at least 7 days wash out period between each dose of study intervention.	Drug: GSK3640254 Tablet; GSK3640254 tablets will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.; Drug: GSK3640254 Capsule; GSK3640254 capsules will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.
Experimental: Sequence 2 - Treatment BADC Participants will receive a single dose of GSK3640254 200 mg (Treatment B- Test), tablets, orally under moderate fat conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment A- Reference), capsules, orally under moderate fat conditions on Day 1 in second intervention period; followed by GSK3640254 200 mg (Treatment D- Test), tablets, orally under high fat conditions on Day 1 in third intervention period; further followed by GSK3640254 200 mg (Treatment C- Reference), tablets, orally under fasted conditions on Day 1 in fourth intervention period. There will be at least 7 days wash out period between each dose of study intervention.	Drug: GSK3640254 Tablet; GSK3640254 tablets will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.; Drug: GSK3640254 Capsule; GSK3640254 capsules will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.
Experimental: Sequence 3 - Treatment CDAB Participants will receive a single dose of GSK3640254 200 mg (Treatment C- Reference), tablets, orally under fasted conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment D- Test), tablets, orally under high fat conditions on Day 1 in second intervention period; followed by GSK3640254 200 mg (Treatment A- Reference), capsules, orally under moderate fat conditions on Day 1 in third intervention period; further followed by GSK3640254 200 mg (Treatment B- Test), tablets, orally under moderate fat conditions on Day 1 in first intervention period. There will be at least 7 days wash out period between each dose of study intervention.	Drug: GSK3640254 Tablet; GSK3640254 tablets will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.; Drug: GSK3640254 Capsule; GSK3640254 capsules will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.
Experimental: Sequence 4 - Treatment DCBA Participants will receive a single dose of GSK3640254 200 mg (Treatment D- Test), tablets, orally under high fat conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment C- Reference), tablets, orally under fasted conditions on Day 1 in second intervention period; followed by GSK3640254 200 mg (Treatment B- Test), tablets, orally under moderate fat conditions on Day 1 in third intervention period; further followed by GSK3640254 200 mg (Treatment A- Reference), capsules, orally under moderate fat conditions on Day 1 in first intervention period. There will be at least 7 days wash out period between each dose of study intervention.	Drug: GSK3640254 Tablet; GSK3640254 tablets will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.; Drug: GSK3640254 Capsule; GSK3640254 capsules will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.

Outcome Measures

Primary Outcome Measures

1. Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-infinity]) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B) [Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

   Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.

2. AUC(0-infinity) for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D) [Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

   Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

3. Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B) [Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

   Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

4. AUC(0-t) for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D) [Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

   Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

5. Maximum Observed Concentration (Cmax) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B) [Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

   Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

6. Cmax for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D) [Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

   Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

7. Time of Cmax (Tmax) for GSK3640254 200 mg Capsules Under Fed Condition (Treatment A) [Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

   Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

8. Time of Cmax (Tmax) for GSK3640254 200 mg Tablets Under Fed, Fasted and High Fat Condition (Treatment B, C and D) [Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

   Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Secondary Outcome Measures

1. Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) [Up to Day 14]

   An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of study medication.

2. Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count [Day 2]

   Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count.

3. Absolute Values for Hematology Parameter: Hemoglobin [Day 2]

   Blood samples were collected to analyze the hematology parameter: hemoglobin.

4. Absolute Values for Hematology Parameter: Hematocrit [Day 2]

   Blood samples were collected to analyze the hematology parameter: hematocrit.

5. Absolute Values for Hematology Parameter: Erythrocytes [Day 2]

   Blood samples were collected to analyze the hematology parameter: erythrocytes.

6. Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume [Day 2]

   Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.

7. Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin [Day 2]

   Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.

8. Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen [Day 2]

   Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.

9. Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase [Day 2]

   Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.

10. Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin [Day 2]

    Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.

11. Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein [Day 2]

    Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.

12. Absolute Values for Chemistry Parameters: Amylase, Lipase [Day 2]

    Blood samples were collected to analyze the chemistry parameters: amylase and lipase.

13. Absolute Values for Urine Parameter: Specific Gravity [Day 2]

    Urine samples were collected to analyze the urine parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine.

14. Absolute Values for Urine Parameter: Urobilinogen [Day 2]

    Urine samples were collected to analyze the urine parameter: urobilinogen.

15. Absolute Values for Urine Parameter: Potential of Hydrogen (pH) [Day 2]

    Urine samples were collected to analyze the urine parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0).

16. Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) [Day 1: 2 hours and 4 hours]

    Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.

17. Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [Days 2, 3, 4, and 5]

    SBP and DBP were measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions.

18. Absolute Values for Pulse Rate [Days 2, 3, 4, and 5]

    Pulse rate was measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions.

19. Absolute Values for Respiratory Rate [Days 2, 3, 4, and 5]

    Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.

20. Absolute Values for Body Temperature [Days 2, 3, 4, and 5]

    Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.

21. Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count [Baseline (Day -1) and at Day 2]

    Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

22. Change From Baseline in Hematology Parameter: Hemoglobin [Baseline (Day -1) and at Day 2]

    Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

23. Change From Baseline in Hematology Parameter: Hematocrit [Baseline (Day -1) and at Day 2]

    Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

24. Change From Baseline in Hematology Parameter: Erythrocytes [Baseline (Day -1) and at Day 2]

    Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

25. Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume [Baseline (Day -1) and at Day 2]

    Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

26. Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin [Baseline (Day -1) and at Day 2]

    Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

27. Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen [Baseline (Day -1) and at Day 2]

    Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

28. Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase [Baseline (Day -1) and at Day 2]

    Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

29. Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin [Baseline (Day -1) and at Day 2]

    Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

30. Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein [Baseline (Day -1) and at Day 2]

    Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

31. Change From Baseline in Chemistry Parameters: Amylase, Lipase [Baseline (Day -1) and at Day 2]

    Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

32. Change From Baseline in Urinalysis Parameter: Specific Gravity [Baseline (Day -1) and at Day 2]

    Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

33. Change From Baseline in Urinalysis Parameter: Urobilinogen [Baseline (Day -1) and at Day 2]

    Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

34. Change From Baseline in Urinalysis Parameter: pH [Baseline (Day -1) and at Day 2]

    Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

35. Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB [Baseline (Day 1, Pre-dose), Day 1: 2 hours and 4 hours]

    Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

36. Change From Baseline in SBP and DBP [Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5]

    SBP and DBP were measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

37. Change From Baseline in Pulse Rate [Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5]

    Pulse rate was measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

38. Change From Baseline in Respiratory Rate [Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5]

    Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

39. Change From Baseline in Body Temperature [Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5]

    Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

40. Lag Time for Absorption (Tlag) for GSK3640254 [Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

41. Apparent Terminal Phase Half-life (t1/2) for GSK3640254 [Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

42. Apparent Oral Clearance (CL/F) for GSK3640254 [Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

43. Apparent Volume of Distribution (Vz/F) for GSK3640254 [Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

44. Plasma Pharmacokinetic Concentration of GSK3640254 [Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK Concentration Population included all participants who underwent plasma PK sampling and had evaluable PK assay results.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

• Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.

• Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).

• Body weight >=50.0 kilogram (kg) (110 pounds [lbs]) for men and >=45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 31.0 kg per square meter (m^2) (inclusive).

• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male or female: Female participants: 1. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: a. not a woman of childbearing potential (WOCBP); or Is a WOCBP and using a nonhormonal contraceptive method that is highly effective, with a failure rate of <1 percent (%), for 28 days before intervention, during the intervention period, and for at least 28 days after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. 2. A WOCBP must have a negative highly sensitive serum pregnancy test at Screening and Day -1. 3. Additional requirements for pregnancy testing during and after study intervention.

• The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions.

Exclusion Criteria

• Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

• A pre-existing condition interfering with normal gastrointestinal (GI) anatomy or motility (example [e.g.], gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study intervention or render the participant unable to take oral study intervention.

• Any history of significant underlying psychiatric disorder, including, but not limited to, schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder.

• Any history of major depressive disorder with or without suicidal features, or anxiety disorders that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient treatment. Participants with other conditions such as adjustment disorder or dysthymia that have required shorter term medical therapy (<6 months) without inpatient treatment and are currently well-controlled clinically or resolved may be considered for entry after discussion and agreement with the Medical Monitor.

• Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse), which, in the opinion of the investigator (with or without psychiatric evaluation), could interfere with the participant's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the participant.

• Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome.

• Presence of hepatitis B surface antigen at Screening or within 3 months prior to starting study intervention.

• Positive hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention and positive on reflex to hepatitis C ribonucleic acid.

• Positive Human immunodeficiency virus-1 and -2 antigen/antibody immunoassay at Screening.

• ALT >1.5 × upper limit of normal (ULN). A single repeat of ALT is allowed within a single Screening period to determine eligibility.

• Bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). A single repeat of any laboratory abnormality is allowed within a single Screening period to determine eligibility.

• Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.

• Any Grade 2 to 4 laboratory abnormality at Screening, with the exception of creatine phosphokinase and lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT, will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A single repeat of any laboratory abnormality is allowed within a single Screening period to determine eligibility.

• A positive test result for drugs of abuse (including marijuana), alcohol, or cotinine (indicating active current smoking) at Screening or before the first dose of study intervention.

• Unable to refrain from the use of prescription or non-prescription drugs including vitamins, herbal and dietary supplements (including Saint John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study intervention and for the duration of the study.

• Treatment with any vaccine within 30 days prior to receiving study intervention.

• Unwillingness to abstain from excessive consumption of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos or their fruit juices within 7 days prior to the first dose of study intervention(s) until the end of the study.

• Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) 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 study intervention (whichever is longer).

• Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 56 days.

• Any positive (abnormal) response confirmed by the investigator on a screening clinician- or qualified designee-administered Columbia Suicide Severity Rating Scale (C-SSRS).

• Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction in the past 3 months, symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, non sustained or sustained ventricular tachycardia, second degree atrioventricular block Mobitz Type II, third degree atrioventricular block, complete heart block, or conduction abnormality) which, in the opinion of the investigator or Medical Monitor, will interfere with the safety for the individual participant.

• Exclusion criteria for Screening ECG (a single repeat is allowed for eligibility determination): Heart rate: male <45 or >100 beats per minute (bpm) and female <50 or

100 bpm, and QTcF interval: male >450 millisecond (ms), female >450 ms.

• History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 units. One unit is equivalent to 8 grams of alcohol: a half pint (~240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits.

• Unable to refrain from tobacco or nicotine-containing products within 3 months prior to 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Austin	Texas	United States	78744

Sponsors and Collaborators

• ViiV Healthcare

Investigators

• Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

• Study Protocol - Aug 30, 2019
• Statistical Analysis Plan - Jan 15, 2020

More Information

Publications

None provided.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT04128293
• Other Study ID Numbers: 209713
• First Posted: Oct 16, 2019
• Last Update Posted: Aug 25, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ViiV Healthcare: Healthy participants; GSK3640254; Human immunodeficiency virus (HIV); Safety
• Additional relevant MeSH terms: HIV Infections

Study Results

Participant Flow

Recruitment Details	This was a randomized, open-label, single dose, 4 period crossover study in healthy participants conducted at a single center in the United States.
Pre-assignment Detail	A total of 16 participants were enrolled in this study. The study was early terminated by sponsor due to a potential contamination issue in the study drug after completion of treatment Period 2. Hence, treatment Periods 3 and 4 were not conducted.

Arm/Group Title	Sequence 1 - Treatment ABCD	Sequence 2 - Treatment BADC	Sequence 3 - Treatment CDAB	Sequence 4 - Treatment DCBA
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between two treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 4. Treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between two treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between 2 treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between 2 treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
Period Title: Treatment Period 1 (1 Day)
STARTED	4	4	4	4
COMPLETED	4	4	4	4
NOT COMPLETED	0	0	0	0
Period Title: Treatment Period 1 (1 Day)
STARTED	4	4	4	4
COMPLETED	4	4	4	4
NOT COMPLETED	0	0	0	0
Period Title: Treatment Period 1 (1 Day)
STARTED	4	4	4	4
COMPLETED	4	4	4	4
NOT COMPLETED	0	0	0	0
Period Title: Treatment Period 1 (1 Day)
STARTED	4	4	4	4
COMPLETED	0	0	0	0
NOT COMPLETED	4	4	4	4
Period Title: Treatment Period 1 (1 Day)
STARTED	0	0	0	0
COMPLETED	0	0	0	0
NOT COMPLETED	0	0	0	0
Period Title: Treatment Period 1 (1 Day)
STARTED	0	0	0	0
COMPLETED	0	0	0	0
NOT COMPLETED	0	0	0	0
Period Title: Treatment Period 1 (1 Day)
STARTED	0	0	0	0
COMPLETED	0	0	0	0
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Sequence 1 - Treatment ABCD	Sequence 2 - Treatment BADC	Sequence 3 - Treatment CDAB	Sequence 4 - Treatment DCBA	Total
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between two treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 4. Treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between two treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between 2 treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between 2 treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.	Total of all reporting groups
Overall Participants	4	4	4	4	16
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	33.8 (8.46)	33.8 (10.21)	31.3 (7.68)	38.0 (11.66)	34.2 (8.97)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	1 25%	1 25%	2 12.5%
Male	4 100%	4 100%	3 75%	3 75%	14 87.5%
Race/Ethnicity, Customized (Count of Participants)
Asian - South East Asian Heritage	0 0%	0 0%	1 25%	0 0%	1 6.3%
Black or African American	2 50%	4 100%	2 50%	2 50%	10 62.5%
White-White/Caucasian/European Heritage	2 50%	0 0%	1 25%	2 50%	5 31.3%

Outcome Measures

1. Primary Outcome

Title	Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-infinity]) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B)
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.
Time Frame	Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8
Geometric Mean (Geometric Coefficient of Variation) [Hours*microgram per milliliter]	35.51 (16.7)	31.16 (37.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment A- GSK3640254 200 mg Capsules (Fed), Treatment B- GSK3640254 200 mg Tablet (Fed)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Geometric Least Square Mean
	Estimated Value	0.877
	Confidence Interval	(2-Sided) 90%; 0.7585 to 1.0152
	Parameter Dispersion	Type: Value:
	Estimation Comments	Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of AUC(0-infinity).

2. Primary Outcome

Title	AUC(0-infinity) for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D)
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	6	8
Geometric Mean (Geometric Coefficient of Variation) [Hours*microgram per milliliter]	15.54 (49.4)	37.85 (30.1)

3. Primary Outcome

Title	Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B)
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8
Geometric Mean (Geometric Coefficient of Variation) [Hours*microgram per milliliter]	33.05 (18.2)	29.50 (37.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment A- GSK3640254 200 mg Capsules (Fed), Treatment B- GSK3640254 200 mg Tablet (Fed)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Geometric Least Square Mean
	Estimated Value	0.892
	Confidence Interval	(2-Sided) 90%; 0.7778 to 1.0239
	Parameter Dispersion	Type: Value:
	Estimation Comments	Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of AUC(0-t).

4. Primary Outcome

Title	AUC(0-t) for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D)
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	6	8
Geometric Mean (Geometric Coefficient of Variation) [Hours*microgram per milliliter]	14.43 (52.3)	34.99 (29.1)

5. Primary Outcome

Title	Maximum Observed Concentration (Cmax) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B)
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8
Geometric Mean (Geometric Coefficient of Variation) [Microgram per milliliter]	1.151 (16.8)	1.088 (23.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment A- GSK3640254 200 mg Capsules (Fed), Treatment B- GSK3640254 200 mg Tablet (Fed)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Geometric Least Square Mean
	Estimated Value	0.946
	Confidence Interval	(2-Sided) 90%; 0.8594 to 1.0404
	Parameter Dispersion	Type: Value:
	Estimation Comments	Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of Cmax.

6. Primary Outcome

Title	Cmax for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D)
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	6	8
Geometric Mean (Geometric Coefficient of Variation) [Microgram per milliliter]	0.5557 (71.3)	1.168 (30.0)

7. Primary Outcome

Title	Time of Cmax (Tmax) for GSK3640254 200 mg Capsules Under Fed Condition (Treatment A)
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
Measure Participants	8
Median (Full Range) [Hours]	6.000

8. Primary Outcome

Title	Time of Cmax (Tmax) for GSK3640254 200 mg Tablets Under Fed, Fasted and High Fat Condition (Treatment B, C and D)
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	6	8
Median (Full Range) [Hours]	5.033	4.250	4.500

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment A- GSK3640254 200 mg Capsules (Fed), Treatment B- GSK3640254 200 mg Tablet (Fed)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4252
	Comments	The p-value was assessed based on the Wilcoxon signed-rank test.
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	0.533
	Confidence Interval	(2-Sided) 90%; -1.0000 to 2.0000
	Parameter Dispersion	Type: Value:
	Estimation Comments	The median difference and the 90 percent (%) confidence interval of the median difference was estimated from Hodges-Lehmann estimate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Treatment B- GSK3640254 200 mg Tablet (Fed), Treatment D- GSK3640254 200 mg Tablet (High Fat)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3125
	Comments	The p-value was assessed based on the Wilcoxon rank sum test.
	Method	Wilcoxon rank sum test
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	1.000
	Confidence Interval	(2-Sided) 90%; -0.7500 to 5.2500
	Parameter Dispersion	Type: Value:
	Estimation Comments	The median difference and the 90% confidence interval of the median difference were estimated from Hodges-Lehmann estimate.

9. Secondary Outcome

Title	Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of study medication.
Time Frame	Up to Day 14

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Any AEs	0 0%	1 25%	0 0%	1 25%
Any SAEs	0 0%	0 0%	0 0%	0 0%

10. Secondary Outcome

Title	Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Description	Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count.
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Basophils	0.024 (0.0092)	0.028 (0.0175)	0.036 (0.0119)	0.038 (0.0139)
Eosinophils	0.086 (0.0472)	0.096 (0.0910)	0.126 (0.0761)	0.128 (0.0740)
Lymphocytes	1.673 (0.3314)	1.689 (0.2283)	1.890 (0.4366)	1.753 (0.4307)
Monocytes	0.365 (0.0849)	0.384 (0.0968)	0.434 (0.1492)	0.410 (0.1610)
Neutrophils	2.324 (0.6459)	2.403 (0.6452)	2.470 (0.6709)	2.403 (0.6713)
Platelet count	252.1 (22.64)	241.5 (28.91)	271.8 (44.08)	270.9 (40.47)

11. Secondary Outcome

Title	Absolute Values for Hematology Parameter: Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter: hemoglobin.
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Mean (Standard Deviation) [Grams per liter]	145.1 (8.61)	143.1 (8.63)	144.8 (14.50)	145.5 (12.81)

12. Secondary Outcome

Title	Absolute Values for Hematology Parameter: Hematocrit
Description	Blood samples were collected to analyze the hematology parameter: hematocrit.
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Mean (Standard Deviation) [Proportion of red blood cells in blood]	0.4406 (0.02272)	0.4344 (0.02477)	0.4294 (0.04147)	0.4345 (0.03691)

13. Secondary Outcome

Title	Absolute Values for Hematology Parameter: Erythrocytes
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes.
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Mean (Standard Deviation) [10^12 cells per liter]	5.199 (0.3468)	5.120 (0.3829)	5.013 (0.5337)	5.066 (0.4719)

14. Secondary Outcome

Title	Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Mean (Standard Deviation) [Femtoliter]	84.88 (4.055)	85.00 (4.184)	85.84 (4.373)	85.90 (4.178)

15. Secondary Outcome

Title	Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Mean (Standard Deviation) [Picograms]	28.01 (1.864)	28.06 (1.905)	28.94 (1.614)	28.73 (1.424)

16. Secondary Outcome

Title	Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Description	Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Glucose	4.774 (0.2447)	4.780 (0.1336)	4.843 (0.3617)	4.838 (0.2467)
Cholesterol	4.853 (1.0266)	4.630 (0.8081)	5.028 (1.5207)	4.960 (1.3009)
Triglycerides	1.048 (0.5887)	0.989 (0.6469)	1.509 (1.1537)	1.379 (0.8660)
Anion gap	9.8 (1.58)	9.9 (1.25)	11.1 (2.03)	10.9 (1.64)
Calcium	2.473 (0.0453)	2.430 (0.0609)	2.421 (0.1025)	2.431 (0.1005)
Carbon dioxide	31.8 (1.16)	31.3 (1.04)	30.1 (2.30)	30.5 (1.93)
Chloride	101.1 (0.99)	101.0 (1.60)	101.5 (2.14)	101.6 (1.92)
Phosphate	1.173 (0.1278)	1.201 (0.0606)	1.199 (0.1929)	1.230 (0.1292)
Potassium	4.56 (0.334)	4.50 (0.239)	4.28 (0.282)	4.36 (0.272)
Sodium	138.1 (0.99)	137.5 (2.00)	138.5 (1.31)	138.4 (1.19)
Blood urea nitrogen	4.785 (0.9271)	4.509 (1.1031)	4.351 (1.0179)	4.096 (0.8941)

17. Secondary Outcome

Title	Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
Description	Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Creatine kinase	116.1 (36.01)	116.8 (48.18)	94.8 (44.83)	111.9 (55.35)
Lactate dehydrogenase	125.8 (9.54)	122.1 (20.33)	120.1 (18.18)	122.3 (17.77)
ALT	18.1 (3.09)	15.0 (3.46)	17.9 (14.22)	18.5 (15.32)
ALP	61.1 (8.89)	58.3 (8.07)	57.5 (14.82)	60.8 (20.15)
AST	15.5 (2.39)	14.4 (2.56)	15.6 (3.11)	16.1 (3.56)
Gamma-glutamyl transferase	18.3 (7.74)	17.5 (7.54)	28.4 (24.07)	28.3 (21.26)

18. Secondary Outcome

Title	Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Description	Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Urate	289.9 (60.74)	282.6 (60.69)	287.0 (72.44)	276.6 (60.99)
Creatinine	92.84 (12.612)	92.71 (12.136)	84.95 (13.200)	82.78 (13.843)
Bilirubin	10.85 (2.838)	10.78 (3.283)	12.24 (5.172)	11.09 (4.149)
Direct bilirubin	2.04 (0.526)	2.13 (0.607)	2.29 (1.241)	2.14 (1.041)

19. Secondary Outcome

Title	Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Description	Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Albumin	45.8 (1.49)	44.0 (1.77)	45.9 (2.85)	46.4 (3.20)
Globulin	27.8 (3.20)	27.1 (4.02)	25.3 (3.11)	25.8 (2.92)
Protein	73.5 (2.56)	71.1 (3.36)	71.1 (3.98)	72.1 (5.06)

20. Secondary Outcome

Title	Absolute Values for Chemistry Parameters: Amylase, Lipase
Description	Blood samples were collected to analyze the chemistry parameters: amylase and lipase.
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Amylase	53.8 (11.51)	54.3 (14.39)	66.3 (26.29)	68.8 (24.84)
Lipase	19.6 (10.00)	21.6 (13.67)	21.6 (11.69)	22.9 (10.08)

21. Secondary Outcome

Title	Absolute Values for Urine Parameter: Specific Gravity
Description	Urine samples were collected to analyze the urine parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine.
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Mean (Standard Deviation) [Ratio]	1.0169 (0.00666)	1.0108 (0.00774)	1.0165 (0.00590)	1.0150 (0.00632)

22. Secondary Outcome

Title	Absolute Values for Urine Parameter: Urobilinogen
Description	Urine samples were collected to analyze the urine parameter: urobilinogen.
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Mean (Standard Deviation) [Micromoles per liter]	3.3860 (0.00000)	5.0790 (4.78853)	8.4650 (7.00969)	5.0790 (4.78853)

23. Secondary Outcome

Title	Absolute Values for Urine Parameter: Potential of Hydrogen (pH)
Description	Urine samples were collected to analyze the urine parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0).
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Mean (Standard Deviation) [pH]	6.38 (0.518)	6.31 (0.704)	6.31 (0.530)	6.13 (0.641)

24. Secondary Outcome

Title	Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB)
Description	Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.
Time Frame	Day 1: 2 hours and 4 hours

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
PR Interval: Day 1, 2 hours	173.3 (9.62)	173.4 (11.07)	158.3 (17.85)	156.9 (18.37)
PR Interval: Day 1, 4 hours	174.4 (11.25)	173.0 (9.55)	157.5 (14.29)	149.6 (17.07)
QRS Duration: Day 1, 2 hours	90.9 (6.60)	94.3 (6.02)	91.5 (11.10)	92.6 (10.68)
QRS Duration: Day 1, 4 hours	90.5 (5.88)	91.4 (7.95)	91.3 (9.13)	92.1 (6.58)
QT Interval: Day 1, 2 hours	372.1 (22.03)	372.8 (21.74)	405.8 (25.73)	387.6 (29.34)
QT Interval: Day 1, 4 hours	393.0 (22.55)	391.0 (25.95)	411.5 (30.29)	398.3 (23.92)
QTcF Interval: Day 1, 2 hours	374.8 (14.41)	376.0 (20.09)	406.1 (23.12)	399.9 (19.79)
QTcF Interval: Day 1, 4 hours	380.9 (18.00)	381.1 (15.37)	406.5 (24.60)	410.6 (20.85)
QTcB Interval: Day 1, 2 hours	376.3 (13.54)	377.9 (20.92)	406.6 (26.45)	406.8 (24.77)
QTcB Interval: Day 1, 4 hours	375.1 (18.55)	376.5 (12.93)	404.5 (28.43)	417.4 (24.86)

25. Secondary Outcome

Title	Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Description	SBP and DBP were measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions.
Time Frame	Days 2, 3, 4, and 5

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
SBP: Day 2	116.0 (8.05)	115.1 (6.77)	116.4 (10.25)	118.3 (15.00)
SBP: Day 3	116.4 (8.85)	115.6 (10.34)	117.1 (7.57)	115.6 (9.66)
SBP: Day 4	114.6 (8.45)	117.6 (13.10)	113.6 (11.33)	116.5 (12.25)
SBP: Day 5	113.4 (8.58)	113.9 (10.58)	113.8 (9.29)	113.6 (7.01)
DBP: Day 2	69.4 (6.61)	69.6 (6.61)	71.0 (8.16)	71.0 (12.73)
DBP: Day 3	65.3 (7.52)	66.3 (9.75)	68.6 (7.13)	71.9 (9.28)
DBP: Day 4	68.8 (9.71)	68.9 (10.76)	72.0 (9.38)	73.4 (9.55)
DBP: Day 5	70.0 (10.09)	68.3 (11.65)	72.4 (7.95)	70.6 (6.70)

26. Secondary Outcome

Title	Absolute Values for Pulse Rate
Description	Pulse rate was measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions.
Time Frame	Days 2, 3, 4, and 5

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Day 2	60.0 (6.19)	61.3 (9.79)	66.0 (11.75)	64.5 (7.91)
Day 3	62.5 (7.54)	61.4 (9.07)	63.4 (8.94)	67.9 (9.57)
Day 4	62.9 (9.51)	61.9 (7.20)	67.1 (8.39)	64.5 (10.84)
Day 5	60.4 (8.47)	62.8 (11.21)	67.4 (5.76)	65.8 (9.27)

27. Secondary Outcome

Title	Absolute Values for Respiratory Rate
Description	Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame	Days 2, 3, 4, and 5

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Day 2	14.3 (2.71)	13.8 (2.25)	14.0 (2.83)	14.0 (3.55)
Day 3	15.8 (1.98)	15.5 (2.33)	14.3 (1.98)	14.3 (2.25)
Day 4	16.0 (0.00)	16.0 (1.07)	14.5 (1.41)	14.3 (2.25)
Day 5	15.8 (3.62)	15.3 (3.01)	15.8 (2.25)	14.5 (3.51)

28. Secondary Outcome

Title	Absolute Values for Body Temperature
Description	Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame	Days 2, 3, 4, and 5

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Day 2	36.15 (0.378)	36.28 (0.292)	36.15 (0.548)	36.16 (0.407)
Day 3	36.13 (0.219)	36.34 (0.297)	36.19 (0.230)	36.11 (0.429)
Day 4	36.21 (0.295)	36.09 (0.242)	36.26 (0.407)	36.21 (0.253)
Day 5	36.33 (0.238)	36.41 (0.309)	36.24 (0.213)	36.36 (0.385)

29. Secondary Outcome

Title	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Description	Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day -1) and at Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Basophils	-0.001 (0.0099)	0.003 (0.0149)	-0.004 (0.0074)	-0.003 (0.0071)
Eosinophils	-0.005 (0.0338)	0.005 (0.0278)	0.009 (0.0259)	0.010 (0.0169)
Lymphocytes	-0.170 (0.3945)	-0.154 (0.5025)	0.015 (0.1927)	-0.123 (0.1959)
Monocytes	-0.015 (0.0487)	0.004 (0.0721)	0.019 (0.0884)	-0.005 (0.0767)
Neutrophils	-0.214 (0.4939)	-0.135 (0.2945)	-0.166 (0.7631)	-0.234 (0.5199)
Platelet count	18.3 (22.63)	7.6 (11.84)	6.1 (18.76)	5.3 (18.38)

30. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day -1) and at Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Mean (Standard Deviation) [Grams per liter]	6.0 (4.34)	4.0 (4.93)	3.3 (6.50)	4.0 (7.33)

31. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hematocrit
Description	Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day -1) and at Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Mean (Standard Deviation) [Proportion of red blood cells in blood]	0.0179 (0.01374)	0.0116 (0.01430)	0.0063 (0.01884)	0.0114 (0.01963)

32. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Erythrocytes
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day -1) and at Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Mean (Standard Deviation) [10^12 cells per liter]	0.241 (0.1604)	0.163 (0.1521)	0.100 (0.2321)	0.154 (0.2329)

33. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day -1) and at Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Mean (Standard Deviation) [Femtoliter]	-0.61 (0.416)	-0.49 (0.582)	-0.45 (0.672)	-0.39 (0.340)

34. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day -1) and at Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Mean (Standard Deviation) [Picograms]	-0.10 (0.245)	-0.05 (0.220)	0.09 (0.387)	-0.13 (0.306)

35. Secondary Outcome

Title	Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Description	Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day -1) and at Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Glucose	-0.055 (0.3778)	-0.049 (0.2568)	-0.168 (0.2530)	-0.173 (0.3159)
Cholesterol	0.498 (0.7449)	0.275 (0.4277)	0.310 (0.4079)	0.243 (0.3383)
Triglycerides	0.026 (0.1434)	-0.033 (0.1849)	0.013 (0.5576)	-0.118 (0.4461)
Anion gap	-0.9 (1.89)	-0.8 (2.25)	-0.6 (1.41)	-0.9 (2.17)
Calcium	0.095 (0.0674)	0.053 (0.0794)	0.026 (0.0713)	0.036 (0.0965)
Carbon dioxide	1.4 (1.19)	0.9 (1.46)	1.3 (0.89)	1.6 (1.51)
Chloride	0.3 (1.49)	0.1 (2.17)	-0.1 (1.25)	0.0 (1.85)
Phosphate	-0.006 (0.1165)	0.023 (0.1499)	0.044 (0.1327)	0.075 (0.1144)
Potassium	0.33 (0.238)	0.26 (0.226)	0.08 (0.198)	0.16 (0.239)
Sodium	0.4 (1.60)	-0.3 (2.25)	0.4 (1.30)	0.3 (1.58)
Blood urea nitrogen	-0.049 (0.8640)	-0.325 (0.7951)	0.090 (1.7057)	-0.165 (1.4390)

36. Secondary Outcome

Title	Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Description	Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day -1) and at Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Creatine kinase	-54.3 (60.14)	-53.6 (72.20)	-24.5 (24.18)	-7.4 (34.16)
Lactate dehydrogenase	-9.6 (16.62)	-13.3 (19.02)	-12.9 (8.22)	-10.8 (7.81)
ALT	1.0 (2.56)	-2.1 (3.00)	0.4 (2.50)	1.0 (2.00)
ALP	-0.9 (8.11)	-3.8 (4.77)	-3.0 (5.58)	0.3 (3.73)
AST	-1.1 (2.03)	-2.3 (2.38)	-0.5 (1.07)	0.0 (2.73)
Gamma-glutamyl transferase	1.4 (2.13)	0.6 (1.77)	-1.1 (1.46)	-1.3 (6.45)

37. Secondary Outcome

Title	Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Description	Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day -1) and at Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Urate	-6.3 (18.71)	-13.5 (28.10)	-14.1 (37.84)	-24.5 (50.08)
Creatinine	1.66 (6.736)	1.54 (6.292)	1.75 (8.188)	-0.43 (7.123)
Bilirubin	3.13 (2.364)	3.05 (2.117)	1.13 (4.318)	-0.03 (4.639)
Direct bilirubin	0.43 (0.590)	0.51 (0.449)	0.06 (0.609)	-0.09 (0.762)

38. Secondary Outcome

Title	Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Description	Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day -1) and at Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Albumin	1.5 (2.83)	-0.3 (2.38)	0.1 (1.55)	0.6 (2.67)
Globulin	0.5 (1.85)	-0.1 (2.30)	-0.4 (2.13)	0.1 (2.42)
Protein	2.0 (4.60)	-0.4 (3.78)	-0.3 (2.87)	0.8 (4.77)

39. Secondary Outcome

Title	Change From Baseline in Chemistry Parameters: Amylase, Lipase
Description	Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day -1) and at Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Amylase	1.0 (9.29)	1.5 (10.21)	4.0 (5.98)	6.5 (6.32)
Lipase	-9.5 (16.34)	-7.5 (9.93)	-3.9 (3.87)	-2.6 (6.25)

40. Secondary Outcome

Title	Change From Baseline in Urinalysis Parameter: Specific Gravity
Description	Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day -1) and at Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Mean (Standard Deviation) [Ratio]	0.0034 (0.01006)	-0.0028 (0.01341)	-0.0009 (0.01284)	-0.0024 (0.01097)

41. Secondary Outcome

Title	Change From Baseline in Urinalysis Parameter: Urobilinogen
Description	Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day -1) and at Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Mean (Standard Deviation) [Micromoles per liter]	-1.6930 (4.78853)	0.0000 (7.23957)	1.6930 (8.67994)	-1.6930 (4.78853)

42. Secondary Outcome

Title	Change From Baseline in Urinalysis Parameter: pH
Description	Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day -1) and at Day 2

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Mean (Standard Deviation) [pH]	0.25 (0.463)	0.19 (0.651)	0.44 (0.623)	0.25 (0.926)

43. Secondary Outcome

Title	Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
Description	Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose), Day 1: 2 hours and 4 hours

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
PR Interval: Day 1, 2 hours	-6.3 (3.81)	2.3 (8.24)	-0.3 (5.85)	5.4 (14.35)
PR Interval: Day 1, 4 hours	-5.1 (4.79)	1.9 (6.24)	-1.0 (7.21)	-1.9 (15.87)
QRS Duration: Day 1, 2 hours	1.4 (3.81)	3.5 (6.74)	0.3 (4.46)	1.6 (5.29)
QRS Duration: Day 1, 4 hours	1.0 (5.37)	0.6 (4.44)	0.0 (4.44)	1.1 (3.14)
QT Interval: Day 1, 2 hours	-10.9 (11.37)	-15.6 (12.64)	5.5 (7.96)	-12.6 (13.98)
QT Interval: Day 1, 4 hours	10.0 (16.40)	2.6 (10.69)	11.3 (13.72)	-2.0 (15.30)
QTcF Interval: Day 1, 2 hours	-6.9 (8.92)	-10.5 (6.57)	-0.1 (6.36)	-7.5 (8.00)
QTcF Interval: Day 1, 4 hours	-0.8 (11.34)	-5.4 (6.67)	0.3 (7.74)	3.3 (4.89)
QTcB Interval: Day 1, 2 hours	-4.8 (14.38)	-8.1 (13.15)	-3.1 (8.79)	-4.6 (11.84)
QTcB Interval: Day 1, 4 hours	-5.9 (16.44)	-9.5 (9.81)	-5.3 (11.66)	6.0 (5.37)

44. Secondary Outcome

Title	Change From Baseline in SBP and DBP
Description	SBP and DBP were measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
SBP: Day 2	-0.1 (3.87)	-2.0 (4.54)	-1.8 (6.94)	3.4 (10.42)
SBP: Day 3	0.3 (3.20)	-1.5 (7.31)	-1.0 (6.70)	0.8 (4.74)
SBP: Day 4	-1.5 (8.96)	0.5 (9.21)	-4.5 (7.54)	1.6 (6.59)
SBP: Day 5	-2.8 (6.41)	-3.3 (7.09)	-4.4 (9.29)	-1.3 (6.36)
DBP: Day 2	-2.3 (4.65)	-3.0 (6.50)	-1.9 (4.55)	-0.9 (6.56)
DBP: Day 3	-6.4 (7.98)	-6.4 (5.78)	-4.3 (4.83)	0.0 (3.38)
DBP: Day 4	-2.9 (7.00)	-3.8 (7.76)	-0.9 (6.53)	1.5 (5.78)
DBP: Day 5	-1.6 (4.75)	-4.4 (7.56)	-0.5 (4.69)	-1.3 (5.28)

45. Secondary Outcome

Title	Change From Baseline in Pulse Rate
Description	Pulse rate was measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Day 2	-2.0 (4.84)	-0.6 (6.67)	1.4 (6.95)	1.4 (3.85)
Day 3	0.5 (6.07)	-0.5 (4.38)	-1.3 (5.55)	4.8 (5.97)
Day 4	0.9 (5.44)	0.0 (7.93)	2.5 (4.34)	1.4 (6.25)
Day 5	-1.6 (5.60)	0.9 (4.94)	2.8 (3.20)	2.6 (7.85)

46. Secondary Outcome

Title	Change From Baseline in Respiratory Rate
Description	Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Day 2	-0.3 (4.83)	0.3 (2.71)	-0.5 (2.33)	0.3 (3.62)
Day 3	1.3 (2.12)	2.0 (3.21)	-0.3 (1.98)	0.5 (2.56)
Day 4	1.5 (2.56)	2.5 (2.07)	0.0 (2.14)	0.5 (3.16)
Day 5	1.3 (5.65)	1.8 (4.06)	1.3 (1.83)	0.8 (3.37)

47. Secondary Outcome

Title	Change From Baseline in Body Temperature
Description	Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	8	8
Day 2	-0.10 (0.374)	-0.10 (0.227)	-0.15 (0.469)	-0.10 (0.417)
Day 3	-0.13 (0.433)	-0.04 (0.311)	-0.11 (0.253)	-0.15 (0.389)
Day 4	-0.04 (0.262)	-0.29 (0.429)	-0.04 (0.450)	-0.05 (0.288)
Day 5	0.08 (0.354)	0.04 (0.256)	-0.06 (0.250)	0.10 (0.342)

48. Secondary Outcome

Title	Lag Time for Absorption (Tlag) for GSK3640254
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	6	8
Median (Full Range) [Hours]	0.000	0.000	0.000	0.000

49. Secondary Outcome

Title	Apparent Terminal Phase Half-life (t1/2) for GSK3640254
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	6	8
Geometric Mean (Geometric Coefficient of Variation) [Hours]	23.607 (18.7)	22.001 (12.3)	22.948 (29.2)	24.448 (22.3)

50. Secondary Outcome

Title	Apparent Oral Clearance (CL/F) for GSK3640254
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	6	8
Geometric Mean (Geometric Coefficient of Variation) [Liters per hour]	5.632 (16.7)	6.418 (37.4)	12.87 (49.4)	5.284 (30.1)

51. Secondary Outcome

Title	Apparent Volume of Distribution (Vz/F) for GSK3640254
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	6	8
Geometric Mean (Geometric Coefficient of Variation) [Liters]	191.8 (30.8)	203.7 (42.7)	426.1 (70.7)	186.4 (33.5)

52. Secondary Outcome

Title	Plasma Pharmacokinetic Concentration of GSK3640254
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK Concentration Population included all participants who underwent plasma PK sampling and had evaluable PK assay results.
Time Frame	Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Concentration Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)	Treatment B- GSK3640254 200 mg Tablet (Fed)	Treatment C- GSK3640254 200 mg Tablet (Fasted)	Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.	Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
Measure Participants	8	8	6	8
Pre-dose	NA (NA)	7.863 (NA)	3.227 (NA)	NA (NA)
1 hour	14.83 (NA)	68.15 (70.107)	61.22 (75.133)	443.0 (456.37)
1.5 hours	62.30 (87.234)	291.1 (304.32)	145.5 (121.20)	696.0 (627.36)
2 hours	148.5 (176.30)	486.0 (352.74)	273.2 (206.53)	837.6 (602.91)
2.5 hours	293.4 (267.01)	746.1 (448.03)	371.0 (261.44)	946.3 (477.31)
3 hours	490.3 (384.97)	893.4 (398.47)	412.4 (286.00)	1009 (402.66)
3.5 hours	647.1 (375.90)	926.3 (194.74)	477.2 (345.06)	976.3 (339.08)
4 hours	759.3 (334.79)	955.8 (253.23)	541.0 (463.54)	1024 (350.97)
4.5 hours	919.1 (287.70)	1027 (320.44)	624.0 (475.10)	1027 (290.12)
5 hours	1057 (172.77)	1024 (278.55)	560.3 (407.61)	1067 (321.21)
6 hours	1129 (204.39)	1006 (231.01)	523.5 (319.40)	1001 (245.94)
8 hours	1020 (201.61)	890.6 (277.11)	471.8 (294.06)	922.1 (238.72)
12 hours	793.1 (134.74)	713.6 (247.97)	359.5 (226.80)	795.3 (206.96)
24 hours	581.8 (156.89)	519.8 (184.90)	262.7 (140.32)	597.5 (175.90)
48 hours	268.0 (52.285)	240.5 (84.134)	124.2 (50.302)	281.6 (75.989)
72 hours	131.0 (26.340)	116.5 (38.362)	56.97 (16.732)	147.8 (56.122)
96 hours	67.26 (18.506)	52.96 (17.846)	28.18 (11.700)	78.38 (39.314)

Adverse Events

Time Frame	AEs and SAEs were collected from start of the treatment (Day 1) up to Day 14
Adverse Event Reporting Description	Safety Population consisted of all participants who received at least 1 dose of study medication. Data is presented for Periods 1 and 2 only as data was not collected in Periods 3 and 4 due to early termination of the study following completion of Period 2.
Arm/Group Title	Treatment A- GSK3640254 200 mg Capsules (Fed)		Treatment B- GSK3640254 200 mg Tablet (Fed)		Treatment C- GSK3640254 200 mg Tablet (Fasted)		Treatment D- GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description	Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.		Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.		Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.		Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
All Cause Mortality
	Treatment A- GSK3640254 200 mg Capsules (Fed)		Treatment B- GSK3640254 200 mg Tablet (Fed)		Treatment C- GSK3640254 200 mg Tablet (Fasted)		Treatment D- GSK3640254 200 mg Tablet (High Fat)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/8 (0%)
Serious Adverse Events
	Treatment A- GSK3640254 200 mg Capsules (Fed)		Treatment B- GSK3640254 200 mg Tablet (Fed)		Treatment C- GSK3640254 200 mg Tablet (Fasted)		Treatment D- GSK3640254 200 mg Tablet (High Fat)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Treatment A- GSK3640254 200 mg Capsules (Fed)		Treatment B- GSK3640254 200 mg Tablet (Fed)		Treatment C- GSK3640254 200 mg Tablet (Fasted)		Treatment D- GSK3640254 200 mg Tablet (High Fat)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		1/8 (12.5%)		0/8 (0%)		1/8 (12.5%)
Injury, poisoning and procedural complications
Arthropod bite	0/8 (0%)		1/8 (12.5%)		0/8 (0%)		0/8 (0%)
Skin abrasion	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/8 (12.5%)

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.