A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-297 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD), and the Effect of Food on EDP-297 Pharmacokinetics in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- EDP-297
- Conditions
- NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis
- Sponsor
- Enanta Pharmaceuticals, Inc
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Safety measured by adverse events
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
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 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 -
- •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.
Arms & Interventions
EDP-297 SAD Cohorts
EDP-297 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral solution, once daily in one single administration
Intervention: EDP-297
EDP-297 MAD Cohorts
EDP-297 Dose 1, Dose 2 and Dose 3 oral solution, once daily for 14 days
Intervention: EDP-297
EDP-297 SAD Placebo Cohort
Matching placebo, oral solution, once daily in one single administration
Intervention: Placebo
EDP-297 MAD Placebo Cohort
Matching placebo, oral solution, once daily for 14 days
Intervention: Placebo
Outcomes
Primary Outcomes
Safety measured by adverse events
Time Frame: Up to 21 Days in MAD Cohorts
Secondary Outcomes
- Cmax of EDP-297(Up to 18 Days in MAD Cohorts)
- AUC of EDP-297(Up to 18 Days in MAD Cohorts)