A Single Ascending Dose Study of BMS-791325 in HCV Infected Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: BMS-791325; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00664625

AI443-002

Details and patient eligibility

About

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-791325 in subjects with chronic hepatitis C infection

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronically infected with HCV genotype 1
• Treatment naive or treatment non-responders or treatment intolerant
• HCV RNA viral load of ≥10*5* IU/mL
• BMI 18 to 35 kg/m²

Exclusion criteria

• Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
• Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
• Co-infection with HIV or HBV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 4 patient groups

1

Experimental group

Description:

BMS-791325 (100 mg) or placebo match for (100 mg)

Treatment:

Drug: Placebo

Drug: BMS-791325

2

Experimental group

Description:

BMS-791325 (300 mg) or placebo match for (300 mg)

Treatment:

Drug: Placebo

Drug: BMS-791325

3

Experimental group

Description:

BMS-791325 (900 mg) or placebo match for (900 mg)

Treatment:

Drug: Placebo

Drug: BMS-791325

4

Experimental group

Description:

BMS-791325 (potential dose between 10-800 mg) or placebo match for (10-800 mg)

Treatment:

Drug: Placebo

Drug: BMS-791325