A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: Placebo; Drug: Daclatasvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00546715

AI444-002

Details and patient eligibility

About

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

Enrollment: 95 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Chronically infected with hepatitis C virus genotype 1
• Treatment naive or treatment non-responders or treatment intolerant; and not co-infected with HIV or hepatitis B virus
• Hepatitis C virus RNA viral load of ≥ 10*5* IU/mL
• BMI 18 to 35 kg/m²

Key Exclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 4 patient groups

Dose Panel A

Active Comparator group

Description:

Daclatasvir - 1 mg Placebo - 0 mg

Treatment:

Drug: Placebo

Drug: Daclatasvir

Dose Panel B

Active Comparator group

Description:

Daclatasvir - 10 mg Placebo - 0 mg

Treatment:

Drug: Placebo

Drug: Daclatasvir

Dose Panel C

Active Comparator group

Description:

Daclatasvir - 100 mg Placebo - 0 mg

Treatment:

Drug: Placebo

Drug: Daclatasvir

Dose Panel D

Active Comparator group

Description:

Daclatasvir - 0.5 - 200 mg (to be determined) Placebo - 0 mg

Treatment:

Drug: Placebo

Drug: Daclatasvir