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Clinical trial

A Phase 1, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TMC647055 in Combination With a Pharmacokinetic Enhancer (Part 1) Followed by an Open-label, Randomized, 3-way Crossover Study to Evaluate Short-term Safety, Tolerability and Pharmacokinetics of the Coadministration of TMC435, TMC647055 and a Pharmacokinetic Enhancer, at Steady-state (Part 2) in Healthy Japanese Subjects.

NCT02064842 is registered in ClinicalTrials.gov with Janssen R&D Ireland as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 1, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TMC647055 in Combination With a Pharmacokinetic Enhancer (Part 1) Followed by an Open-label, Randomized, 3-way Crossover Study to Evaluate Short-term Safety, Tolerability and Pharmacokinetics of the Coadministration of TMC435, TMC647055 and a Pharmacokinetic Enhancer, at Steady-state (Part 2) in Healthy Japanese Subjects.
Lead sponsor
Janssen R&D Ireland
Phase
Phase 1
Overall status
Completed
Start date
February 28, 2014
Completion date
April 30, 2014
Enrollment
24 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

healthy