A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TMC647055 in Combination With Ritonavir (Part 1) and the Co-administration of TMC435, TMC647055 and Ritonavir (Part 2) in Healthy Japanese Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
Healthy
Interventions
DRUG

TMC647055

TMC647055 150 mg (1 capsule), 450 mg (3 capsules), 600 mg (4 capsules) taken orally (by mouth) once daily on Day 1 in Part 1. TMC647055 450 mg (3 capsules), and 600 mg (4 capsules) taken orally once daily on Days 1 to 7 in Part 2

DRUG

TMC435

TMC435 1 capsule of 75 mg, 100 mg, and 150 mg taken orally on Days 1 to 7 in Part 2

DRUG

Placebo

Placebo capsule once daily taken orally on Day 1 in Part 1

DRUG

Ritonavir (RTV)

RTV 30 mg (ie, 0.38 mL oral solution of RTV \[80 mg/mL strength\]) taken orally on Day 1 in Part 1 and on Days 1 to 7 in Part 2

Trial Locations (1)

Unknown

Harrow

All Listed Sponsors
lead

Janssen R&D Ireland

INDUSTRY

NCT02064842 - A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TMC647055 in Combination With Ritonavir (Part 1) and the Co-administration of TMC435, TMC647055 and Ritonavir (Part 2) in Healthy Japanese Participants | Biotech Hunter | Biotech Hunter