This randomized, double-blind, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-938 in healthy adult subjects
The first phase assesses single ascending doses for EDP-938 (active drug or placebo) in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect. The second phase assesses multiple ascending doses (active drug or placebo) for 7-days in healthy subjects. Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-938 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-938 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
Pharmaceutical Research Associates, Inc.,
Lenexa, Kansas, United States
Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).
Time frame: Up to 8 days
Cmax of EDP-938
Time frame: Up to 5 Days
Cmax of EDP-938
Time frame: Up to 11 Days
AUC of EDP-938
Time frame: Up to 5 Days
AUC of EDP-938
Time frame: Up to 11 Days
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