NCT00990145

Multiple Ascending-Dose Study of EDP 322 in Healthy Adult Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Safety, Tolerability, and Pharmacokinetics Study of EDP-322 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This was a Phase I, single-center, randomized, double-blind, placebo-controlled, ascending multiple dose study to evaluate the safety, tolerability, and pharmacokinetics of orally administered EDP-322 in healthy adult volunteers.

Detailed description

Fifty-two subjects were enrolled into 6 cohorts. Six subjects of each cohort were randomized to received EDP-322 and 2 subjects of each cohort received placebo. Each cohort received the study drug once daily (QD) for 7 days under fed conditions. Multiple oral doses of EDP 322 ranging from 200 to 800 mg were safe and generally well tolerated by the healthy male and female subjects in this study.

Conditions

• MRSA, SSTI

Interventions

Type	Name	Description
DRUG	EDP-322

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-03-01
• Completion: 2009-09-01
• First posted: 2009-10-06
• Last updated: 2009-10-08

Locations

1 site across 1 country: United States