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

Completed · Phase 1 · Has a placebo group

Conditions studied: HCV Infection

In brief

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.

Key facts

Study ID

NCT01193478

Run by

Gilead Sciences

People needed

71

Starts

2010-08-01

Expected to finish

2011-12-01

Last updated by the study team

2013-01-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Anaheim, California, United States
• Study site — Cypress, California, United States
• Study site — National City, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — DeLand, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — St Louis, Missouri, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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