Evaluation of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of EDP-788

Phase 1TerminatedNCT02255968

Enanta Pharmaceuticals, Inc16 enrolled

Overview

The primary objective of the study is to determine the safety and tolerability of multiple doses of orally administered EDP-788. Secondary objectives of the study are to describe the pharmacokinetics of EDP-788 (and its metabolite EDP-322) after multiple doses of orally administered drug.

Three cohorts of subjects will be enrolled to receive either EDP-788 or placebo. The dose of EDP-788 will be increased with each successive cohort. In addition, a 4th cohort may be enrolled, depending on clinical findings (tolerability, safety, pharmacokinetics) observed in the first 3 cohorts. In each cohort, 8 subjects will receive a q12h oral dose regimen of EDP-788 (6 subjects) or placebo (2 subjects). All subjects receive multiple doses of study drug (EDP-788 or placebo).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

EDP-788DRUG

EDP-788 Capsules. All interventions are given as multiple doses.

PlaceboDRUG

Matching placebo capsules. All interventions are given as multiple doses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion Criteria: * In good general health * BMI between 18 - 32 kg/m2 * Women must be of non-childbearing potential (surgically sterilized) * Normal electrocardiogram * Willing to abstain from strenuous physical exercise starting 3 days prior to admission to the study clinic through the 17 - 19 day post-dosing visit Key Exclusion Criteria: * Hypersensitivity to macrolide antibiotics * Abnormal laboratory values * Gastroenteritis within 1 week of study drug administration * Use of any investigational drugs within 28 days of study drug administration * History of gastrointestinal surgery which may interfere with drug absorption * Active Hepatitis B, Hepatitis C, or HIV infection * Use of prescription or non-prescription drugs within 14 days of study drug administration * Use of nicotine within 3 months of study drug administration

Locations (1)

PPD Phase 1 Clinic

Austin, Texas, United States

Outcomes

Primary Outcomes

Incidence and severity of adverse events

Time frame: From time of dosing to 20-23 days after receiving last dose of study drug

Secondary Outcomes

Changes from baseline in laboratory values and vital signs

Time frame: From time of dosing to 20-23 days after receiving last dose of study drug

Pharmacokinetic parameters

As measured by peak plasma concentration (Cmax)

Time frame: From time of dosing to 3 days after receiving the last dose of study drug

Data from ClinicalTrials.gov

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