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

Enanta Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Safety in Normal Volunteers

Treatments

Drug: EDP-788

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01999725

EDP788-001

Details and patient eligibility

About

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

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 8 - 10 day post-dosing visit

Key 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