Single and Multiple Ascending Dose, First-in- Human Study in Healthy Subjects

Sponsor

Theravance Biopharma (Industry)

Overall Status

Completed

CT.gov ID

NCT04044339

Collaborator

(none)

Enrollment

Location

Arms

3.6

Actual Duration (Months)

15.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 2 parts: Part A is a single ascending dose (SAD) study in healthy subjects and Part B is a multiple ascending dose (MAD) study in healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: TD-5202 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Double-blind, Randomized, Placebo-controlled, Sponsor-open, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-5202 in Healthy Subjects

Actual Study Start Date :

Aug 8, 2019

Actual Primary Completion Date :

Nov 27, 2019

Actual Study Completion Date :

Nov 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TD-5202 for SAD (Part A) 6 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive TD-5202	Drug: TD-5202 Study Drug to be administered orally
Placebo Comparator: Placebo for SAD (Part A) 2 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive placebo	Drug: Placebo Placebo to be administered orally
Experimental: TD-5202 for MAD (Part B) 6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-5202	Drug: TD-5202 Study Drug to be administered orally
Placebo Comparator: Placebo for MAD (Part B) 2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo.	Drug: Placebo Placebo to be administered orally

Outcome Measures

Primary Outcome Measures

To assess the safety and tolerability of SAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events [Day 1 through Day 8]
To assess the safety and tolerability of MAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events [Day 1 through Day 17]
Pharmacokinetics (PK) of TD-5202 when given as an SAD: AUC [Day 1 through Day 4]
Area under the plasma concentration-time curve (AUC)
Pharmacokinetics (PK) of TD-5202 when given as a SAD: Cmax [Day 1 through Day 4]
Maximum observed concentration (Cmax)
Pharmacokinetics (PK) of TD-5202 when given as a SAD: Tmax [Day 1 through Day 4]
Time to reach maximum observed concentration (Tmax)
PK of TD-5202 when given as an SAD: CL/F [Day 1 through Day 4]
Oral Clearance (CL/F)
PK of TD-5202 when given as an SAD: Vz/F [Day 1 through Day 4]
Terminal Phase Volume of Distribution(Vz/F)
PK of TD-5202 when given as an SAD: Kel [Day 1 through Day 4]
Elimination Rate (Kel)
PK of TD-5202 when given as an SAD: t 1/2 [Day 1 through Day 4]
Halflife (t 1/2)
PK of TD-5202 when given as an MAD: AUC [Day 1 and Day 10]
Area under the plasma concentration-time curve (AUC)
PK of TD-5202 when given as an MAD: Cmax [Day 1 and Day 10]
Maximum observed concentration (Cmax)
PK of TD-5202 when given as an MAD: Tmax [Day 1 and Day 10]
Time to reach maximum observed concentration (Tmax)
PK of TD-5202 when given as an MAD: C trough [Day 2, 4, 6, 8]
concentration at trough (after multiple dosing usually after reaching steady state) (C trough)
PK of TD-5202 when given as an MAD: Css [Day 10]
concentration at steady state (Css)
PK of TD-5202 when given as an MAD: CL/Fss [Day 10]
Oral clearance at steady state (CL/Fss)
PK of TD-5202 when given as an MAD: Cmin [Day 10]
Concentration minimum (after single dosing) (Cmin)
PK of TD-5202 when given as an MAD: Vz/Fss [Day 10]
Terminal phase volume of distribution at steady state (Vz/Fss)
PK of TD-5202 when given as an MAD: Kel [Day 10]
Elimination Rate (Kel)
PK of TD-5202 when given as an MAD: t 1/2 [Day 10]
Halflife (t 1/2)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female, 19 - 55 years old
Willing and able to give informed consent and comply with the study
Medically healthy with no clinically significant medical history
Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
Males must use acceptable contraception
Additional inclusion criteria apply

Exclusion Criteria:

Positive for hepatitis A, B or C, HIV or tuberculosis
Clinically significant abnormalities of laboratory evaluations
Have abnormal ECG or vital sign measurements
Any acute illness at time of screening
Have a current bacterial, parasitic, fungal or viral infection
Uses or have used tobacco or nicotine-containing products within 6 months prior to screening
Additional inclusion criteria apply