A Study of EDP-297 in Healthy Subjects

Sponsor

Enanta Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT04559126

Collaborator

PRA Health Sciences (Industry)

Enrollment

Location

Arms

9.4

Actual Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis	Drug: EDP-297 Drug: Placebo	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 8, 2020

Actual Primary Completion Date :

Jun 21, 2021

Actual Study Completion Date :

Jun 21, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.