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

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

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

Sponsors & Collaborators

• Boehringer Ingelheim

  lead INDUSTRY

Principal Investigators

• Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2013-12-31

Completion

2014-10-31

Countries

• United States
• Canada
• Germany

Study Locations