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
1 other identifier
interventional
71
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2010
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 31, 2010
CompletedFirst Posted
Study publicly available on registry
September 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJanuary 21, 2013
January 1, 2013
5 months
August 31, 2010
January 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
Study Arms (6)
Cohort 1
ACTIVE COMPARATORGS-5885 (3 mg), once daily or matching placebo, once daily
Cohort 2
ACTIVE COMPARATORGS-5885 (10 mg), once daily or matching placebo, once daily
Cohort 3
ACTIVE COMPARATORGS-5885 (30 mg), once daily or matching placebo, once daily
Cohort 4
ACTIVE COMPARATORGS-5885 ( up to 90 mg), once daily or matching placebo, once daily
Cohort 5
ACTIVE COMPARATORGS-5885 (up to 90 mg), once daily or matching placebo, once daily
Cohort 6 (optional)
ACTIVE COMPARATORGS-5885 (up to 90 mg), once daily or matching placebo, once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (13)
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Cypress, California, 90630, United States
Unknown Facility
National City, California, 91950, United States
Unknown Facility
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
Miami, Florida, 33169, United States
Unknown Facility
Orlando, Florida, 32809, United States
Unknown Facility
St Louis, Missouri, 63104, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Philadelphia, Pennsylvania, 19139, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
San Antonio, Texas, 78215, United States
Unknown Facility
Tacoma, Washington, 98418, United States
Related Publications (1)
Wong KA, Worth A, Martin R, Svarovskaia E, Brainard DM, Lawitz E, Miller MD, Mo H. Characterization of Hepatitis C virus resistance from a multiple-dose clinical trial of the novel NS5A inhibitor GS-5885. Antimicrob Agents Chemother. 2013 Dec;57(12):6333-40. doi: 10.1128/AAC.02193-12. Epub 2013 Jul 22.
PMID: 23877691DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Diana Brainard, MD
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2010
First Posted
September 2, 2010
Study Start
August 1, 2010
Primary Completion
January 1, 2011
Study Completion
December 1, 2011
Last Updated
January 21, 2013
Record last verified: 2013-01