Completed

1b

82

US

GS-9669 tablets, Cohort 1 (N = 10, genotype 1a): 100 mg GS-9669 or placebo BID with, food [total daily dose (TDD) = 200 mg] for 3 days;, Cohort 2 (N = 10, genotype 1a): 400 mg GS-9669 or placebo BID with, food (TDD = 800 mg) for 3 days;, Cohorts 1 and 2 may be conducted in parallel. Additional adaptive BID, and/or QD cohorts (Cohorts 3-5) in genotype 1a subjects may be, conducted depending on the safety, virology, and available, pharmacokinetics from the first two cohorts. Cohorts 3 -5 may be, conducted in parallel if the total daily dose is lower than the highest total, daily dose previously tested and determined to be safe and well tolerated., Cohort 3 (N = 10, genotype 1a): up to 400 mg GS-9669 or placebo BID, with food (TDD = up to 800 mg) for 3 days;, Cohort 4 (N = 10, genotype 1a): up to 400 mg GS-9669 or placebo BID, Cohort 5 (N=10, genotype 1a): up to 800 mg GS-9669 or placebo QD in, the morning with food (TDD = up to 800 mg) for 3 days;, Based on the results of Cohorts 1 to 5, one or more regimens will be, selected for an evaluation in genotype 1b subjects to enable comparison, between genotypes. Cohorts 6 and 7 may proceed in parallel with other, Cohorts if the total daily dose is the same or lower than the highest total, Cohort 6 (N = 10, genotype 1b): up to 400 mg GS-9669 or placebo BID, with food (TDD = up to 800 mg) for 3 days, Cohort 7 (N = 10, genotype 1b): up to 800 mg GS-9669 or placebo QD in, the morning with food (TDD = up to 800 mg) for 3 days., Placebo to Match GS-9669 tablet

Gilead Sciences

Hepatitis C

12/11

05/12