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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: HCV Infection

Treatments: Drug: Placebo; Drug: GS-5885

Study type: Interventional

Funder types: Industry

Identifiers

NCT01193478

GS-US-256-0102

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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71 participants in 6 patient groups

Cohort 1

Active Comparator group

Description:

GS-5885 (3 mg), once daily or matching placebo, once daily

Treatment:

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Cohort 2

Active Comparator group

Description:

GS-5885 (10 mg), once daily or matching placebo, once daily

Treatment:

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Cohort 3

Active Comparator group

Description:

GS-5885 (30 mg), once daily or matching placebo, once daily

Treatment:

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Cohort 4

Active Comparator group

Description:

GS-5885 ( up to 90 mg), once daily or matching placebo, once daily

Treatment:

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Cohort 5

Active Comparator group

Description:

GS-5885 (up to 90 mg), once daily or matching placebo, once daily

Treatment:

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Cohort 6 (optional)

Active Comparator group

Description:

GS-5885 (up to 90 mg), once daily or matching placebo, once daily

Treatment:

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885

Drug: GS-5885

Drug: Placebo

Drug: Placebo

Drug: GS-5885