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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01193478
First received: August 31, 2010
Last updated: January 18, 2013
Last verified: January 2013

August 31, 2010
January 18, 2013
August 2010
January 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01193478 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Emergence of viral resistance [ Time Frame: Up to 48 weeks following Study Day 14 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
HCV Infection
  • Drug: GS-5885
    tablet, oral, 3 mg once daily for 3 days
  • Drug: Placebo
    tablet, oral, once daily for 3 days
  • Drug: GS-5885
    tablet, oral, 10 mg once daily for 3 days
  • Drug: GS-5885
    tablet, oral, 30 mg once daily for 3 days
  • Drug: GS-5885
    tablet, oral, up to 90 mg once daily for 3 days
  • Active Comparator: Cohort 1
    GS-5885 (3 mg), once daily or matching placebo, once daily
    Interventions:
    • Drug: GS-5885
    • Drug: Placebo
  • Active Comparator: Cohort 2
    GS-5885 (10 mg), once daily or matching placebo, once daily
    Interventions:
    • Drug: GS-5885
    • Drug: Placebo
  • Active Comparator: Cohort 3
    GS-5885 (30 mg), once daily or matching placebo, once daily
    Interventions:
    • Drug: GS-5885
    • Drug: Placebo
  • Active Comparator: Cohort 4
    GS-5885 ( up to 90 mg), once daily or matching placebo, once daily
    Interventions:
    • Drug: GS-5885
    • Drug: Placebo
  • Active Comparator: Cohort 5
    GS-5885 (up to 90 mg), once daily or matching placebo, once daily
    Interventions:
    • Drug: GS-5885
    • Drug: Placebo
  • Active Comparator: Cohort 6 (optional)
    GS-5885 (up to 90 mg), once daily or matching placebo, once daily
    Interventions:
    • Drug: GS-5885
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
December 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01193478
GS-US-256-0102
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Diana Brainard, MD Gilead Sciences
Gilead Sciences
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP