Safety Study of INX-08189, Pharmacokinetic and Pharmacodynamic With Ribavirin and Food Effect Study, in Chronically-infected Genotype 1 Hepatitis C Virus, Treatment-naïve Subjects

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

May 31, 2012

Study Completion Date

May 31, 2012

Conditions
Hepatitis C
Interventions
DRUG

200 mg INX-08189 Fasted

200 mg capsule INX-08189 fasted x7 days

DRUG

Placebo QD Fasted

Placebo capsule QD fasted x7 days

DRUG

100 mg INX-08189 QD

100 mg INX-08189 capsule QD x 7 days

DRUG

Placebo QD

Placebo capsule Placebo QD dosed with ribavirin x7 days (ribavirin will be dosed in a weight-based fashion as labeled BID)

DRUG

100 mg INX-08189 with low-fat meal

INX-08189 100 mg capsule, with low-fat meal QD for seven days

DRUG

Placebo with low-fat meal

Placebo capsule administered with a low-fat meal QD for seven days

DRUG

100 mg INX-08189 BID Fasted

100 mg INX-08189 BID fasted x7 days

DRUG

Placebo BID Fasted

Placebo BID fasted x7 days

DRUG

ribavirin

Trial Locations (2)

78215

San Antonio

00927

San Juan

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY