Evaluation of the Safety and Pharmacokinetics of a Single Oral Dose of EDP-788

NCT ID: NCT01999725

Last Updated: 2015-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-09-30

Brief Summary

The primary objective of the study is to determine the safety of single 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 single doses of orally administered drug
• To estimate the bioavailability of EDP-788 capsules relative to an oral liquid suspension
• To estimate the effect of co-administration of food on the absorption of EDP-788

Detailed Description

Subjects are enrolled in successive cohorts and are randomized to receive either EDP-788 or placebo capsules. If the safety profile of the drug is acceptable, based upon review of blinded data, the cohort receiving the next higher dose will be treated. Up to 8 cohorts will be recruited. All subjects receive a single dose of study drug (EDP-788 or placebo).

Subjects in Cohort C will receive a second single dose of study drug (EDP-788 or placebo) approximately 2 weeks after the first dose. The second dose will be administered as a liquid suspension rather than as a capsule formulation. The purpose of the second dose is to estimate the bioavailability of the capsule formulation relative to the suspension.

Subjects in Cohort E will receive a second single dose of study drug (EDP-788 or placebo) approximately 2 weeks after the first does. The second dose will be administered with a standard test meal. The purpose of the second dose is to estimate the effect of food on absorption of EDP-788.

Conditions

Safety in Normal Volunteers

Study Design

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

Study Groups

EDP-788

Single doses with dose escalation to continue in successive cohorts

Group Type: EXPERIMENTAL

EDP-788

Intervention Type: DRUG

EDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses

Placebo

Single dose with matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo capsules or matching suspension

Interventions

EDP-788

EDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses

Intervention Type: DRUG

Placebo

Matching placebo capsules or matching suspension

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 8 - 10 day post-dosing visit

Exclusion Criteria

• Hypersensitivity to macrolide antibiotics
• Abnormal laboratory values
• 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: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Enanta Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theresa T Pham, MD

Role: PRINCIPAL_INVESTIGATOR

PPD Phase I Clinic

Locations

PPD Phase I Clinic

Austin, Texas, United States

Countries

United States

Other Identifiers

EDP788-001

Identifier Type: -

Identifier Source: org_study_id