A Phase 1 interventional study of GS-6620 and GS-6620 in Hepatitis C, Chronic, sponsored by Gilead Sciences. Completed at 13 sites in 2 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-03-26.
Sponsored by Gilead Sciences · Phase 1 and Interventional
A Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects with Chronic Hepatitis C Virus Infection.
2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 90 is close to the median of 100 across 1,887 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
(N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 50 mg GS-6620 or placebo QD in the morning with food \[total daily dose (TDD) = 50 mg\] for 5 days
Drug: GS-6620
(N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 100 mg GS-6620 or placebo QD in the morning with food (TDD = 100 mg) for 5 days
Drug: GS-6620
Cohort 3 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 300 mg GS 6620 or placebo QD in the morning with food (TDD = 300 mg) for 5 days
Drug: GS-6620
Cohort 4 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 100 mg GS 6620 or placebo QD in the morning without food (TDD = 100 mg) for 5 days
Drug: GS-6620
Cohort 5 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 300 mg GS 6620 or placebo QD in the morning without food (TDD = 300 mg) for 5 days
Drug: GS-6620
Cohort 6 (N = 10, genotype 2 or genotype 3): (Active drug: 8, Matching Placebo: 2) 900 mg GS 6620 or placebo QD in the morning without food (TDD = 900 mg) for 5 days
Drug: GS-6620
Cohort 7 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 450 mg GS 6620 or placebo, administered BID with food (TDD = 900 mg) for 5 days
Drug: GS-6620 tablet, 450 mg BID
Cohort 9 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 900 mg GS 6620 or placebo BID in the with food (TDD = 1800 mg) for 5 days
Drug: GS-6620 tablet
Cohort 11 (N = 10, genotype 1 : (Active drug: 8, Matching Placebo: 2) Up to 450 mg GS-6620 or placebo as an oral solution, BID, 12 hours apart in the fasted state, 2 hours after a meal (up to TDD = up to 900 mg) for 5 days.
Drug: GS-6620 tablet
GS-6620 tablet, 50 mg QD
GS-6620 tablet, 100 mg QD
GS-6620 tablet, 300 mg QD
GS-6620 tablet, 100 mg QD, Fasted
GS-6620 tablet, 300 mg QD, Fasted
GS-6620 tablet, 900 mg QD, Fasted
GS-6620 tablet, 450 mg BID
GS-6620 tablet, 900mg , BID
GS-6620 tablet, 900 mg
Number of subjects with adverse events as a measure of safety and tolerability.
Number of subjects with HCV RNA viral response as a measure of antiviral activity.
Concentrations and pharmacokinetic parameters of GS-6620 and its metabolites will be measured.
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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