A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects

Status:	Completed
Conditions:	Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 60
Updated:	4/21/2016
Start Date:	May 2008
End Date:	June 2009

Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity and Safety, Tolerability, and Pharmacokinetics of Daclatasvir in Subjects Infected With Hepatitis C Virus Genotype 1

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

Inclusion Criteria:

- Chronically infected with Hepatitis C Virus (HCV) genotype 1

- Treatment naive or treatment non-responders or treatment intolerant; and not
co-infected with HIV or Hepatitis B Virus

- 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 Hepatitis C Virus infection

- 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

WOCBP will be enrolled as in-patient for 16 days

We found this trial at

sites

Parexel International Corporation

Baltimore, Maryland 21225

from

Baltimore, MD