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
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.
Sponsor: Janssen R&D Ireland
Listed as NCT02064842, this PHASE1 trial focuses on Healthy and remains completed. Sponsored by Janssen R&D Ireland, it has been updated 6 times since 2014, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
6 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE1
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE1
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE1
▶ Show 1 earlier version
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE1
First recorded
Feb 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Janssen R&D Ireland
For direct contact, visit the study record on ClinicalTrials.gov .