A Study of EDP-297 in Healthy Subjects
Phase 1
Completed
- Conditions
- NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT04559126
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- Brief Summary
This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.
- Detailed Description
The first phase assesses single ascending doses of EDP-297 or placebo in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.
The second phase assesses multiple ascending doses of EDP-297 or placebo for 14-days in healthy subjects.
Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-297 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-297 or placebo
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
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 65 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 -2.
- Current tobacco smokers or use of tobacco within 1 months prior to screening.
- Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
- History of regular alcohol consumption exceeding 14 drinks/week for females and 21 drinks/week for males within 6 months of Screening.
- 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-297 MAD Placebo Cohort Placebo Matching placebo, oral solution, once daily for 14 days EDP-297 SAD Cohorts EDP-297 EDP-297 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral solution, once daily in one single administration EDP-297 MAD Cohorts EDP-297 EDP-297 Dose 1, Dose 2 and Dose 3 oral solution, once daily for 14 days EDP-297 SAD Placebo Cohort Placebo Matching placebo, oral solution, once daily in one single administration
- Primary Outcome Measures
Name Time Method Safety measured by adverse events Up to 21 Days in MAD Cohorts
- Secondary Outcome Measures
Name Time Method Cmax of EDP-297 Up to 18 Days in MAD Cohorts AUC of EDP-297 Up to 18 Days in MAD Cohorts
Trial Locations
- Locations (1)
PRA Health Sciences
🇳🇱Groningen, Netherlands