NCT02018536

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2336805 Alone and With the Co-administration of TMC435 in Healthy Japanese Participants.

A Phase 1, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GSK2336805 (Part 1), Followed by an Open-label, Randomized, 4-way Crossover Study to Evaluate Short-term Safety, Tolerability and Pharmacokinetics of the Co-administration of TMC435 and GSK2336805 at Steady-state (Part 2), in Healthy Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Janssen R&D Ireland · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (what the body does to a medication) of GSK2336805 alone and with the co-administration of TMC435 in healthy Japanese participants.

Detailed description

This study will consists of 2 parts (Part 1 and 2) which will be sequentially conducted in 2 separate panels of 24 healthy adult Japanese participants each, at a single center. Part 1 is a double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (placebo is compared with the study medication to test whether the study medication has a real effect in clinical study), randomized (study medication is assigned by chance), single ascending dose study to investigate the safety, tolerability, and pharmacokinetics of GSK2336805 in participants. It will consist of a screening phase, a treatment phase, and a follow-up phase. The maximum study duration for each participant will be approximately 5 weeks (including screening and follow-up phase). 24 participants will be equally divided in 3 cohorts with 8 participants in each cohort. In each cohort, participants will be randomly assigned to receive either a single oral dose of GSK2336805 (6 participants) or placebo (2 participants). Part 2 is an open-label (all people know the identity of the intervention), randomized, 4-way crossover study (method used to switch patients from one treatment arm to another in a clinical study) to investigate the potential pharmacokinetic drug-drug interactions between TMC435 and GSK2336805 at steady-state, and to evaluate the short-term safety and tolerability when TMC435 and GSK2336805 are co-administered in participants. It will consist of a screening phase, a treatment phase (4 treatment sessions \[Treatment A, B, C, and D\]), and a follow-up phase. The maximum study duration for each participant will be approximately 12 weeks (including screening and follow-up phase). During 4 treatment sessions, each of the 24 participants will receive Treatment A, B, C and D consecutively in different sequences with a washout period of at least 7 days between consecutive treatment sessions in each individual participant. Safety will be evaluated by assessing adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, alcohol breath tests, and specific toxicities.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GSK2336805 30 mg	A single dose of 1 tablet of 30 mg of GSK2336805 taken orally (by mouth) on Day 1 under fasted conditions.
DRUG	GSK2336805 60 mg	A single dose of 2 tablets of 30 mg ie, 60 mg of GSK2336805 taken orally (by mouth) on Day 1 under fasted conditions.
DRUG	GSK2336805 120 mg	A single dose of 4 tablets of 30 mg ie, 120 mg of GSK2336805 taken orally (by mouth) on Day 1 under fasted conditions.
DRUG	TMC435 150 mg (Treatment A)	1 capsule of TMC435 150 mg taken once daily orally (by mouth) on Days 1 to 7 under fed conditions.
DRUG	GSK2336805 60 mg (Treatment B and part of Treatment C and D)	2 tablets of 30 mg GSK2336805 ie, 60 mg of GSK2336805 taken once daily orally (by mouth) on Days 1 to 7 under fed conditions.
DRUG	TMC435 100 mg (part of Treatment C)	1 capsule of TMC435 100 mg taken orally (by mouth) on Days 1 to 7 under fed conditions.
DRUG	TMC435 150 mg (part of treatment D)	1 capsule of TMC435 150 mg taken orally (by mouth) on Days 1 to 7 under fed conditions.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-12-23
• Last updated: 2014-06-17

Locations

1 site across 1 country: United States