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NCT Number: NCT01193478

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

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.

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Key information

Conditions

HCV Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GS-5885

Drug

tablet, oral, 3 mg once daily for 3 days

Placebo

Drug

tablet, oral, once daily for 3 days

Primary outcomes

  1. 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

  2. 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

  1. Measure of GS-5885 plasma concentration over time

    Time frame: Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days

  2. Emergence of viral resistance

    Time frame: Up to 48 weeks following Study Day 14

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 2, 2010
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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