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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 Co-administration of TMC435, TMC647055 and a Pharmacokinetic Enhancer, at Steady-state (Part 2) in Healthy Japanese Subjects.

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Trial Profile

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 Co-administration of TMC435, TMC647055 and a Pharmacokinetic Enhancer, at Steady-state (Part 2) in Healthy Japanese Subjects.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 14 Jan 2020

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At a glance

  • Drugs Simeprevir (Primary) ; TMC 647055 (Primary) ; Ritonavir
  • Indications Hepatitis C; HIV infections
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Janssen R&D Ireland

    • Most Recent Events

    • 29 May 2014 According to the ClinicalTrials.gov record, status changed from recruiting to completed.
    • 29 May 2014 According to the ClinicalTrials.gov record, status changed from not yet recruiting to recruiting.
    • 03 Mar 2014 New trial record

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