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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Enanta Pharmaceuticals

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