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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
71
Unnamed facility
Anaheim, California, United States
Unnamed facility
Cypress, California, United States
Unnamed facility
National City, California, United States
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
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
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
Emergence of viral resistance
Time frame: Up to 48 weeks following Study Day 14
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tablet, oral, once daily for 3 days
tablet, oral, 30 mg once daily for 3 days
tablet, oral, once daily for 3 days
tablet, oral, up to 90 mg once daily for 3 days
tablet, oral, once daily for 3 days
tablet, oral, up to 90 mg once daily for 3 days
tablet, oral, once daily for 3 days
tablet, oral, up to 90 mg once daily for 3 days
tablet, oral, once daily for 3 days
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
DeLand, Florida, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Portland, Oregon, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
...and 3 more locations