A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
NCT ID: NCT01193478
Last Updated: 2013-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
71 participants
INTERVENTIONAL
2010-08-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1
GS-5885 (3 mg), once daily or matching placebo, once daily
GS-5885
tablet, oral, 3 mg once daily for 3 days
Placebo
tablet, oral, once daily for 3 days
Cohort 2
GS-5885 (10 mg), once daily or matching placebo, once daily
GS-5885
tablet, oral, 10 mg once daily for 3 days
Placebo
tablet, oral, once daily for 3 days
Cohort 3
GS-5885 (30 mg), once daily or matching placebo, once daily
GS-5885
tablet, oral, 30 mg once daily for 3 days
Placebo
tablet, oral, once daily for 3 days
Cohort 4
GS-5885 ( up to 90 mg), once daily or matching placebo, once daily
GS-5885
tablet, oral, up to 90 mg once daily for 3 days
Placebo
tablet, oral, once daily for 3 days
Cohort 5
GS-5885 (up to 90 mg), once daily or matching placebo, once daily
GS-5885
tablet, oral, up to 90 mg once daily for 3 days
Placebo
tablet, oral, once daily for 3 days
Cohort 6 (optional)
GS-5885 (up to 90 mg), once daily or matching placebo, once daily
GS-5885
tablet, oral, up to 90 mg once daily for 3 days
Placebo
tablet, oral, once daily for 3 days
Interventions
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GS-5885
tablet, oral, 3 mg once daily for 3 days
Placebo
tablet, oral, once daily for 3 days
GS-5885
tablet, oral, 10 mg once daily for 3 days
Placebo
tablet, oral, once daily for 3 days
GS-5885
tablet, oral, 30 mg once daily for 3 days
Placebo
tablet, oral, once daily for 3 days
GS-5885
tablet, oral, up to 90 mg once daily for 3 days
Placebo
tablet, oral, once daily for 3 days
GS-5885
tablet, oral, up to 90 mg once daily for 3 days
Placebo
tablet, oral, once daily for 3 days
GS-5885
tablet, oral, up to 90 mg once daily for 3 days
Placebo
tablet, oral, once daily for 3 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Diana Brainard, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Anaheim, California, United States
Cypress, California, United States
National City, California, United States
Washington D.C., District of Columbia, United States
DeLand, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
St Louis, Missouri, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
San Antonio, Texas, United States
Tacoma, Washington, United States
Countries
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References
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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.
Other Identifiers
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GS-US-256-0102
Identifier Type: -
Identifier Source: org_study_id
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