A Study of EDP-938 in Healthy Subjects
- Registration Number
- NCT03384823
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- An informed consent document signed and dated by the subject.
- Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
- Clinically relevant evidence or history of illness or disease.
- Pregnant or nursing females.
- History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
- A positive urine drug screen at screening or Day -1.
- Current tobacco smokers or use of tobacco within 3 months prior to screening.
- Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
- History of regular alcohol consumption.
- Participation in a clinical trial within 30 days prior to the first dose of study drug.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EDP-938 SAD Placebo Cohort Placebo Matching placebo, oral suspension, once daily in one single administration EDP-938 SAD Cohorts EDP-938 EDP-938 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration EDP-938 MAD Cohorts EDP-938 EDP-938 Dose 1, Dose 2, Dose 3, and Dose 4 oral suspension, once daily for 7 days EDP-938 MAD Placebo Cohort Placebo Matching placebo, oral suspension, once daily for 7 days
- Primary Outcome Measures
Name Time Method Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis). Up to 8 days
- Secondary Outcome Measures
Name Time Method Cmax of EDP-938 Up to 11 Days AUC of EDP-938 Up to 11 Days
Trial Locations
- Locations (1)
Pharmaceutical Research Associates, Inc.,
🇺🇸Lenexa, Kansas, United States