A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Escalating, Multiple, Oral Doses of GS 5885 in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection
Overview
- Phase
- Phase 1
- Intervention
- GS-5885
- Conditions
- HCV Infection
- Sponsor
- Gilead Sciences
- Enrollment
- 71
- Primary Endpoint
- Number of subjects reporting an adverse event or experiencing a laboratory abnormality
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
Cohort 1
GS-5885 (3 mg), once daily or matching placebo, once daily
Intervention: GS-5885
Cohort 1
GS-5885 (3 mg), once daily or matching placebo, once daily
Intervention: Placebo
Cohort 2
GS-5885 (10 mg), once daily or matching placebo, once daily
Intervention: GS-5885
Cohort 2
GS-5885 (10 mg), once daily or matching placebo, once daily
Intervention: Placebo
Cohort 3
GS-5885 (30 mg), once daily or matching placebo, once daily
Intervention: GS-5885
Cohort 3
GS-5885 (30 mg), once daily or matching placebo, once daily
Intervention: Placebo
Cohort 4
GS-5885 ( up to 90 mg), once daily or matching placebo, once daily
Intervention: GS-5885
Cohort 4
GS-5885 ( up to 90 mg), once daily or matching placebo, once daily
Intervention: Placebo
Cohort 5
GS-5885 (up to 90 mg), once daily or matching placebo, once daily
Intervention: GS-5885
Cohort 5
GS-5885 (up to 90 mg), once daily or matching placebo, once daily
Intervention: Placebo
Cohort 6 (optional)
GS-5885 (up to 90 mg), once daily or matching placebo, once daily
Intervention: GS-5885
Cohort 6 (optional)
GS-5885 (up to 90 mg), once daily or matching placebo, once daily
Intervention: Placebo
Outcomes
Primary Outcomes
Number of subjects reporting an adverse event or experiencing a laboratory abnormality
Time Frame: Safety and tolerability assessments will be performed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days
Antiviral activity measures: measured by change in plasma HCV RNA levels form baseline
Time Frame: Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days
Secondary Outcomes
- Measure of GS-5885 plasma concentration over time(Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days)
- Emergence of viral resistance(Up to 48 weeks following Study Day 14)