Hepatitis C Clinical Trial
Official title:
A Randomized, Double-Blind, Pbo-Controlled, Study of EDP-494 to Evaluate the Safety and PK of SAD/FE in Healthy Subjects and MAD in Healthy and in Subjects With CHC Infection (POC)
This randomized, double-blind study will assess the safety, pharmacokinetics and efficacy of a single and multiple dose(s) of orally QD administered EDP-494 in healthy volunteers (HV) and in treatment-naive subjects with GT1/3 chronic hepatitis C (CHC) infection.
The first phase explores single ascending doses of EDP-494 (active drug or placebo) in
healthy subjects. A 'fasted' vs 'fed' two-part cohort will also assess food effect.
The second phase involves multiple ascending doses (active drug or placebo) for 14 days in
healthy subjects.
The third, proof of concept, phase will assess two different doses for 14 days each in
Hepatitis C patients.
Each cohort within each phase will consist of 8 subjects randomized to either EDP-494 or
placebo in a 3 to 1 ratio, with the exception of the food effect cohort, which will consist
of 10 subjects randomised in a 4 to 1 ratio.
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