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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: EDP-788

• Registration Number: NCT02255968
• Lead Sponsor: Enanta Pharmaceuticals, Inc

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2014-07-29
• Study Start: 2014-08
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted QC: 2014-10-02
• Study First Posted: 2014-10-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-08
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Multiple doses with dose escalation to continue in successive cohorts
EDP-788	EDP-788	Multiple doses with dose escalation to continue in successive cohorts

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events	From time of dosing to 20-23 days after receiving last dose of study drug

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in laboratory values and vital signs	From time of dosing to 20-23 days after receiving last dose of study drug
Pharmacokinetic parameters	From time of dosing to 3 days after receiving the last dose of study drug	As measured by peak plasma concentration (Cmax)

Trial Locations

Locations (1)

PPD Phase 1 Clinic; 🇺🇸 Austin, Texas, United States