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

NCT ID: NCT02255968

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-10-31

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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

EDP-788

Multiple doses with dose escalation to continue in successive cohorts

Group Type: EXPERIMENTAL

EDP-788

Intervention Type: DRUG

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

Placebo

Multiple doses with dose escalation to continue in successive cohorts

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo capsules. All interventions are given as multiple doses

Interventions

EDP-788

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

Intervention Type: DRUG

Placebo

Matching placebo capsules. All interventions are given as multiple doses

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Enanta Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PPD Phase 1 Clinic

Austin, Texas, United States

Countries

United States

Other Identifiers

EDP788-002

Identifier Type: -

Identifier Source: org_study_id