A Study of EDP-297 in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis
• Intervention / Treatment: Drug: EDP-297; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • PRA Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: EDP-297; EDP-297 Oral solution
Experimental: EDP-297 MAD Cohorts; EDP-297 Dose 1, Dose 2 and Dose 3 oral solution, once daily for 14 days	Drug: EDP-297; EDP-297 Oral solution
Placebo Comparator: EDP-297 SAD Placebo Cohort; Matching placebo, oral solution, once daily in one single administration	Drug: Placebo; placebo to match EDP-297
Placebo Comparator: EDP-297 MAD Placebo Cohort; Matching placebo, oral solution, once daily for 14 days	Drug: Placebo; placebo to match EDP-297

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety measured by adverse events	Up to 8 Days in SAD Cohorts
Safety measured by adverse events	Up to 21 Days in MAD Cohorts

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax of EDP-297	Up to 6 Days in SAD Cohorts
Cmax of EDP-297	Up to 18 Days in MAD Cohorts
AUC of EDP-297	Up to 6 Days in SAD Cohorts
AUC of EDP-297	Up to 18 Days in MAD Cohorts

Collaborators and Investigators

• Sponsor: Enanta Pharmaceuticals, Inc
• Collaborators: PRA Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Actual): June 21, 2021
• Study Completion (Actual): June 21, 2021

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Healthy Volunteer; Single Ascending Dose; Multiple Ascending Dose; "First-in-Human"
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: EDP 297-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes