A Study of EDP-297 in Healthy Subjects

Enanta Pharmaceuticals, Inc82 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis

Interventions

EDP-297DRUG

EDP-297 Oral solution

PlaceboDRUG

placebo to match EDP-297

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

PRA Health Sciences

Groningen, Netherlands

Outcomes

Primary Outcomes

Safety measured by adverse events

Time frame: Up to 8 Days in SAD Cohorts

Safety measured by adverse events

Time frame: Up to 21 Days in MAD Cohorts

Secondary Outcomes

Cmax of EDP-297

Time frame: Up to 6 Days in SAD Cohorts

Cmax of EDP-297

Time frame: Up to 18 Days in MAD Cohorts

AUC of EDP-297

Time frame: Up to 6 Days in SAD Cohorts

AUC of EDP-297

Time frame: Up to 18 Days in MAD Cohorts

Data from ClinicalTrials.gov

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