NCT01525628View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

December 31, 2013

Study Completion Date

October 31, 2014

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

Trial Locations (16)

Unknown

1241.27.0006 Boehringer Ingelheim Investigational Site, La Mesa

1241.27.0005 Boehringer Ingelheim Investigational Site, Rockville

1241.27.0004 Boehringer Ingelheim Investigational Site, Marlton

1241.27.0003 Boehringer Ingelheim Investigational Site, Philadelphia

1241.27.0001 Boehringer Ingelheim Investigational Site, Salt Lake City

1241.27.0200 Boehringer Ingelheim Investigational Site, Vancouver

1241.27.0600 Boehringer Ingelheim Investigational Site, Vancouver

1241.27.0700 Boehringer Ingelheim Investigational Site, Vancouver

1241.27.0400 Boehringer Ingelheim Investigational Site, Victoria

1241.27.0100 Boehringer Ingelheim Investigational Site, London

1241.27.0300 Boehringer Ingelheim Investigational Site, Ottawa

1241.27.0500 Boehringer Ingelheim Investigational Site, Montreal

1241.27.4907 Boehringer Ingelheim Investigational Site, Cologne

1241.27.4901 Boehringer Ingelheim Investigational Site, Frankfurt am Main

1241.27.4903 Boehringer Ingelheim Investigational Site, Leipzig

1241.27.4906 Boehringer Ingelheim Investigational Site, Mainz

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY