At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 naïve Patients and Prior Treatment Relapse or Partial Responder Patients With Genotype 1 Chronic Hepatitis C Infection
In Brief
A Phase 1 clinical trial evaluating midazolam, BI 201335, and 6 other interventions for Hepatitis C, Chronic. Completed, enrolled 72 participants across 16 sites in 3 countries.
Detailed Summary
To evaluate the drug-drug interactions between BI 201335 and BI 207127 as well as their combined effect on CYP probe drug substrates and on tenofovir and raltegravir in treatment naive or prior treatment relapse patients with chronic hepatitis C infection.
Study Details
Timeline
Interventions
CYP3A probe drug
HCV protease inhibitor
nucleoside analogue
CYP1A2 probe drug
CYP2C9 probe drug
CYP2C9 probe drug
CYP3A probe drug
CYP1A2 probe drug
HCV treatment
HCV protease inhibitor
HCV protease inhibitor
HCV polymerase inhibitor
HCV polymerase inhibitor
HCV protease inhibitor
HCV polymerase inhibitor
HCV treatment
HCV treatment
HCV treatment
HCV treatment
HCV treatment
CYP1A2 probe drug
CYP2C9 probe drug
HCV polymerase inhibitor
CYP3A probe drug
HCV protease inhibitor
HCV polymerase inhibitor
HCV treatment