A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-305 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD) and the Effect of Food on EDP-305 Pharmacokinetics in Healthy Subjects, and of Multiple Ascending Doses (MAD) in Subjects With Presumptive NAFLD
Overview
- Phase
- Phase 1
- Intervention
- EDP 305
- Conditions
- Presumptive NAFLD
- Sponsor
- Enanta Pharmaceuticals, Inc
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- Safety data including but not limited to adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results (including chemistry, hematology, and urinalysis).
- Status
- Completed
- Last Updated
- 8 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-305 in healthy adult subjects, and adult subjects with presumptive NAFLD (i.e., obese subjects with or without prediabetes or T2DM).
Detailed Description
The first phase assesses single ascending doses for EDP 305 (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 14-days in healthy subjects and also in subjects with presumptive NAFLD (i.e., obese subjects with or without prediabetes or T2DM). Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-305 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-305 or placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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 study drug administration.
- •Use of prescription drugs, non-prescription drugs, dietary supplements including Vitamin E herbal supplements, hormonal therapy/replacement or CYP3A4 substrates, inducers and inhibitors within 14 days prior to the first dose of study medication.
- •Additional Exclusion Criteria for MAD Subjects with Presumptive NAFLD:
Arms & Interventions
EDP 305 SAD Cohorts
EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration
Intervention: EDP 305
EDP 305 MAD Cohorts
EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral suspension, once daily for 14 days
Intervention: EDP 305
EDP 305 SAD Placebo Cohort
Matching placebo, oral suspension, once daily in one single administration
Intervention: Placebo
EDP 305 MAD Placebo Cohort
Matching placebo, oral suspension, once daily for 14 days
Intervention: Placebo
Outcomes
Primary Outcomes
Safety data including but not limited to adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results (including chemistry, hematology, and urinalysis).
Time Frame: From screening to the 7-day post treatment safety follow up visit.
Secondary Outcomes
- AUC(Day 1: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 4, 5, 7, 9, 12; Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24 (D15), 30, 36, 48 (D16), 60, 72 (D17), and 96 (D18) hrs postdose)
- Cmax(Day 1: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 4, 5, 7, 9, 12; Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24 (D15), 30, 36, 48 (D16), 60, 72 (D17), and 96 (D18) hrs postdose)