Overview

A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
Summary
The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype 1 Hepatitis C Virus (HCV) infection. Each participant in the study will be sequestered in the clinic for the initial 5 days of the study.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Ledipasvir
Criteria
Inclusion Criteria:

- Chronically infected with HCV genotype 1

- HCV treatment-naïve

- Not co-infected with HIV or HBV

- HCV RNA viral load of at least 100,000 IU/mL

- BMI 19 to 35 kg/m2

- Subject agrees to use highly effective contraception methods if female of childbearing
potential or sexually active male.

Exclusion Criteria:

- History of clinically-significant illness or any other major medical disorder that may
interfere with subject treatment, assessment or compliance with the protocol

- Decompensated liver disease or cirrhosis or evidence of hepatocellular carcinoma

- Serological evidence of co-infection with human immunodeficiency virus (HIV),
hepatitis B virus (HBV), or another HCV genotype

- Subjects with known, current use of amphetamines and/or cocaine; subjects taking
methadone or buprenorphine (opioid replacement therapy) or ongoing alcohol abuse