Multiple Ascending-Dose Study of EDP 322 in Healthy Adult Volunteers
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Safety, Tolerability, and Pharmacokinetics Study of EDP-322 in Healthy Adult Volunteers|
- The study objective was to determine the safety, tolerability and pharmacokinetics of multiple oral doses of EDP-322 in healthy volunteers. [ Time Frame: Subjects received single doses of the study drug administered QD on Days 1 through 7, with follow-up through Day 11, and as needed. ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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.