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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01193478

Enrollment

Registered

2010-09-02

Start date

2010-08-31

Completion date

2011-12-31

Last updated

2013-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV Infection

Keywords

Hepatitis C, HCV RNA, multiple ascending dose, NS5A, GS-5885, chronic genotype 1 HCV infection

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.

Interventions

DRUGGS-5885

tablet, oral, 3 mg once daily for 3 days

DRUGPlacebo

tablet, oral, once daily for 3 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026