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

Phase 1

Completed

• Conditions: HCV Infection
• Interventions: Drug: GS-5885; Drug: Placebo

• Registration Number: NCT01193478
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-31
• Study First Submitted QC: 2010-08-31
• Study First Posted: 2010-09-02
• Primary Completion: 2011-01
• Study Completion: 2011-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	GS-5885	GS-5885 (3 mg), once daily or matching placebo, once daily
Cohort 1	Placebo	GS-5885 (3 mg), once daily or matching placebo, once daily
Cohort 2	GS-5885	GS-5885 (10 mg), once daily or matching placebo, once daily
Cohort 2	Placebo	GS-5885 (10 mg), once daily or matching placebo, once daily
Cohort 3	Placebo	GS-5885 (30 mg), once daily or matching placebo, once daily
Cohort 4	Placebo	GS-5885 ( up to 90 mg), once daily or matching placebo, once daily
Cohort 5	Placebo	GS-5885 (up to 90 mg), once daily or matching placebo, once daily
Cohort 6 (optional)	GS-5885	GS-5885 (up to 90 mg), once daily or matching placebo, once daily
Cohort 6 (optional)	Placebo	GS-5885 (up to 90 mg), once daily or matching placebo, once daily
Cohort 3	GS-5885	GS-5885 (30 mg), once daily or matching placebo, once daily
Cohort 4	GS-5885	GS-5885 ( up to 90 mg), once daily or matching placebo, once daily
Cohort 5	GS-5885	GS-5885 (up to 90 mg), once daily or matching placebo, once daily

Primary Outcome Measures

Name	Time	Method
Number of subjects reporting an adverse event or experiencing a laboratory abnormality	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	Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days

Secondary Outcome Measures

Name	Time	Method
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