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

NCT02018536 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-06-17

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Janssen R&D Ireland

    lead INDUSTRY

Principal Investigators

  • Janssen R&D Ireland Clinical Trial · Janssen R&D Ireland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02018536 on ClinicalTrials.gov