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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: BMS-650032 or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00559247

AI447-002

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-650032 in subjects with chronic hepatitis C infection

Enrollment: 24 estimated 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 35kg/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
• Women of childbearing potential

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 4 patient groups

or Placebo - Dose Panel 1

Experimental group

Description:

Oral Suspension, 10 mg

Treatment:

Drug: BMS-650032 or Placebo

or Placebo - Dose Panel 2

Experimental group

Description:

Oral Suspension 50 mg

Treatment:

Drug: BMS-650032 or Placebo

or Placebo - Dose Panel 3

Experimental group

Description:

Oral Suspension, 200 mg

Treatment:

Drug: BMS-650032 or Placebo

or Placebo - Dose Panel 4

Experimental group

Description:

Oral Suspension or Solution, 2.5 to 600 mg

Treatment:

Drug: BMS-650032 or Placebo