NCT01999725

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

A Randomized, Double-Blind, Placebo-Controlled, Ascending One-Day (Single and Divided Dose) Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	EDP-788	EDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses
DRUG	Placebo	Matching placebo capsules or matching suspension

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-12-03
• Last updated: 2015-01-09

Locations

1 site across 1 country: United States