Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: BMS-824393

Study type: Interventional

Funder types: Industry

Identifiers

NCT00971308

AI451-002

Details and patient eligibility

About

The purpose of this study is to determine the antiviral effect following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b Hepatitis C virus (HCV) infected subjects.

Enrollment: 37 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment naive chronically infected subjects with Hepatitis C Virus genotype 1
• HCV RNA viral load of ≤10*5* IU/mL (100,000 IU/mL)
• Body Mass Index (BMI) of 18 to 35 kg/m², inclusive

Exclusion criteria

• Women who are pregnant or breast feeding
• Any significant acute or chronic medical illness which is not stable or is not controlled with medication or is not consistent with Hepatitis C infection
• Any other medical, psychiatric and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 5 patient groups

BMS-824393 (Panel 1)

Experimental group

Treatment:

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

BMS-824393 (Panel 2)

Experimental group

Treatment:

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

BMS-824393 (Panel 3)

Experimental group

Treatment:

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

BMS-824393 (Panel 4)

Experimental group

Treatment:

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

BMS-824393 (Panel 5)

Experimental group

Treatment:

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393