NCT02255968

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

A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	EDP-788	EDP-788 Capsules. All interventions are given as multiple doses.
DRUG	Placebo	Matching placebo capsules. All interventions are given as multiple doses

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-10-03
• Last updated: 2015-05-12

Locations

1 site across 1 country: United States