A Phase I, Open Label, 2-Period, Randomized, Crossover Trial in 16 Healthy Subjects to Assess the Drug Interaction Potential of TMC435 With Oral Midazolam and With a Drug Cocktail Representative of CYP1A2, CYP2C9, CYP2D6, CYP3A4, and CYP2C19 Substrates.

Trial Profile

A Phase I, Open Label, 2-Period, Randomized, Crossover Trial in 16 Healthy Subjects to Assess the Drug Interaction Potential of TMC435 With Oral Midazolam and With a Drug Cocktail Representative of CYP1A2, CYP2C9, CYP2D6, CYP3A4, and CYP2C19 Substrates.

Completed
Phase of Trial: Phase I

Latest Information Update: 09 Dec 2009

At a glance

  • Drugs Midazolam; Simeprevir
  • Indications Hepatitis C
  • Focus Pharmacokinetics
  • Sponsors Janssen R&D Ireland
  • Most Recent Events

    • 04 Aug 2009 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 18 May 2009 Actual initiation date (Mar 2009) added as reported by ClinicalTrials.gov.
    • 18 Apr 2009 Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov.
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