A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Chronic Hepatitis C

Treatments

Drug: Placebo

Drug: BMS-650032

Study type

Interventional

Funder types

Industry

Identifiers

NCT00722358

AI447-004

Details and patient eligibility

About

The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection

Enrollment

15 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Chronically infected with HCV genotype 1
Treatment naive
HCV RNA viral load of ≥10*5 IU/mL
BMI 18 to 35kg/m²

Exclusion criteria

Women of childbearing potential (WOCBP)
Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
HCV infected subjects who are treatment non-responder (defined as subject who received at least 12 weeks of SOC and continue to have a detectable HCV RNA level or subjects who did not attain a 2-log decline in HCV RNA levels at 12 weeks and stopped treatment
HCV infected subjects who are treatment intolerant (defined as subject who are unable to receive at least 12 weeks of SOC due to toxicities associated with interferon and/or ribavirin
HIV and/or HBV positive
Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug