A Study of EDP 305 in Healthy Subjects and Subjects With Presumptive NAFLD

Phase 1

Completed

• Conditions: Presumptive NAFLD
• Interventions: Drug: EDP 305; Drug: Placebo

• Registration Number: NCT02918929
• 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-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.

Study Timeline

• Study First Submitted: 2016-08-29
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-29
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

Not provided

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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 -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 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:

• Subjects taking any antidiabetic medication.
• Subjects with unstable proliferative retinopathy, macular oedema (fundus examination performed in the previous year will be considered relevant on Investigator's judgement).
• Subject has taken fibrates, statins, and/or Vitamin E within 6 weeks prior to the first dose administration.
• Subjects with a history of bariatric surgery and any other gastrointestinal surgery relative to weight loss.
• Subjects with common causes of secondary hepatic steatosis.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EDP 305 SAD Cohorts	EDP 305	EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration
EDP 305 MAD Cohorts	EDP 305	EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral suspension, once daily for 14 days
EDP 305 SAD Placebo Cohort	Placebo	Matching placebo, oral suspension, once daily in one single administration
EDP 305 MAD Placebo Cohort	Placebo	Matching placebo, oral suspension, once daily for 14 days

Primary Outcome Measures

Name	Time	Method
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).	From screening to the 7-day post treatment safety follow up visit.

Secondary Outcome Measures

Name	Time	Method
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	EDP 305
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	EDP 305

Trial Locations

Locations (1)

Pharmaceutical Research Associates, Inc.,; 🇺🇸 Lenexa, Kansas, United States