A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-938 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD) and the Effect of Food on EDP-938 Pharmacokinetics in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- EDP-938
- Conditions
- RSV Infection
- Sponsor
- Enanta Pharmaceuticals, Inc
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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 -
- •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.
Arms & Interventions
EDP-938 SAD Cohorts
EDP-938 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration
Intervention: EDP-938
EDP-938 MAD Cohorts
EDP-938 Dose 1, Dose 2, Dose 3, and Dose 4 oral suspension, once daily for 7 days
Intervention: EDP-938
EDP-938 SAD Placebo Cohort
Matching placebo, oral suspension, once daily in one single administration
Intervention: Placebo
EDP-938 MAD Placebo Cohort
Matching placebo, oral suspension, once daily for 7 days
Intervention: Placebo
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Cmax of EDP-938(Up to 11 Days)
- AUC of EDP-938(Up to 11 Days)