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Phase I, Double Blind, Randomized, Placebo-controlled Trial in Healthy Subjects to Examine the Safety, Tolerability and Pharmacokinetics of Increasing Oral Doses of TMC435350 After Single and Repeated Dosing, Followed by an Open Label Repeated Dosing Session in 6 HCV genotype1 Infected Patients.

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Trial Profile

Phase I, Double Blind, Randomized, Placebo-controlled Trial in Healthy Subjects to Examine the Safety, Tolerability and Pharmacokinetics of Increasing Oral Doses of TMC435350 After Single and Repeated Dosing, Followed by an Open Label Repeated Dosing Session in 6 HCV genotype1 Infected Patients.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 22 Apr 2010

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At a glance

  • Drugs Simeprevir (Primary)
  • Indications Hepatitis C
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Janssen R&D Ireland

Most Recent Events

  • 15 Jul 2009 Actual initiation date (1 Jan 2007) added as reported by ClinicalTrials.gov.
  • 15 Jul 2009 Actual end date (1 Sep 2007) added as reported by ClinicalTrials.gov.
  • 15 Jul 2009 New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health, NCT00938899).

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