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.
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
- 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.