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

Status:	Completed
Conditions:	Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 49
Updated:	4/21/2016
Start Date:	November 2007
End Date:	May 2008

Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-790052 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1

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

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

We found this trial at

sites

University Of Virginia Digestive Health Center Of Excellence

Charlottesville, Virginia 22908

from

Charlottesville, VA