NCT01525628

Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	midazolam	CYP3A probe drug
DRUG	BI 201335	HCV protease inhibitor
DRUG	tenofovir	nucleoside analogue
DRUG	caffeine	CYP1A2 probe drug
DRUG	tolbutamide	CYP2C9 probe drug
DRUG	tolbutamide	CYP2C9 probe drug
DRUG	midazolam	CYP3A probe drug
DRUG	caffeine	CYP1A2 probe drug
DRUG	pegylated interferon	HCV treatment
DRUG	BI 201335	HCV protease inhibitor
DRUG	BI 201335	HCV protease inhibitor
DRUG	BI 207127	HCV polymerase inhibitor
DRUG	BI 207127	HCV polymerase inhibitor
DRUG	BI 201335	HCV protease inhibitor
DRUG	BI 207127	HCV polymerase inhibitor
DRUG	ribavirin	HCV treatment
DRUG	ribavirin	HCV treatment
DRUG	ribavirin	HCV treatment
DRUG	pegylated interferon	HCV treatment
DRUG	ribavirin	HCV treatment
DRUG	caffeine	CYP1A2 probe drug
DRUG	tolbutamide	CYP2C9 probe drug
DRUG	BI 207127	HCV polymerase inhibitor
DRUG	midazolam	CYP3A probe drug
DRUG	BI 201335	HCV protease inhibitor
DRUG	BI 207127	HCV polymerase inhibitor
DRUG	ribavirin	HCV treatment

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-12-01
• Completion: 2014-10-01
• First posted: 2012-02-03
• Last updated: 2016-06-10
• Results posted: 2016-06-10

Locations

16 sites across 3 countries: United States, Canada, Germany