A Multi-centre, Open Label, Parallel Group Trial to Evaluate the Pharmacokinetic Interactions Between BI 207127 (600 mg t.i.d. or 600 mg b.i.d.) and BI 201335 (120 mg q.d.) Given in Combination With Ribavirin for 24 Weeks, and Their Combined Effect on the Pharmacokinetics of Tenofovir, Raltegravir, Caffeine (the Probe Drug Substrate for CYP1A2), Tolbutamide (the Probe Drug Substrate for CYP2C9) and Midazolam (the Probe Drug Substrate for CYP3A4) in Treatment naive Patients and Prior Treatment Relapse or Partial Responder Patients With Genotype 1 Chronic Hepatitis C Infection

Trial Profile

A Multi-centre, Open Label, Parallel Group Trial to Evaluate the Pharmacokinetic Interactions Between BI 207127 (600 mg t.i.d. or 600 mg b.i.d.) and BI 201335 (120 mg q.d.) Given in Combination With Ribavirin for 24 Weeks, and Their Combined Effect on the Pharmacokinetics of Tenofovir, Raltegravir, Caffeine (the Probe Drug Substrate for CYP1A2), Tolbutamide (the Probe Drug Substrate for CYP2C9) and Midazolam (the Probe Drug Substrate for CYP3A4) in Treatment naive Patients and Prior Treatment Relapse or Partial Responder Patients With Genotype 1 Chronic Hepatitis C Infection

Completed
Phase of Trial: Phase I

Latest Information Update: 27 Jun 2016

At a glance

  • Drugs Deleobuvir (Primary) ; Faldaprevir (Primary) ; Caffeine; Midazolam; Peginterferon; Raltegravir; Ribavirin; Tenofovir; Tolbutamide
  • Indications Hepatitis C
  • Focus Pharmacokinetics
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 05 Nov 2014 Status changed from active, no longer recruiting to completed, according to ClinicalTrials.gov. record.
    • 19 Mar 2014 Planned number of patients changed from 102 to 72 as reported by ClinicalTrials.gov.
    • 24 Jan 2014 Planned End Date changed from 1 Feb 2015 to 1 Oct 2014 as per ClinicalTrials.gov. record.
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