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

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 Overview

• Status: Completed
• Conditions: MRSA, SSTI
• Intervention / Treatment: Drug: EDP-322

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States
      • PPD Phase I Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adult males or females between 18 and 45 years of age
• Females are eligible if documentation exists that they are surgically sterilized
• In good general health [determined by medical history, physical examination, clinical laboratory tests, and without evidence of a clinically significant abnormality, in the opinion of the investigator and medical monitor.
• Subject has a resting 12-lead ECG at screening that shows no clinically significant abnormality and a Bazett-corrected QT interval less than 450 milliseconds.
• BMI between 18-32 kg/m2
• Subject read, understood, and signed the ICF

Exclusion Criteria:

• History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, CNS, hematologic or metabolic disease, or has an immunologic, emotional, and/or psychiatric disturbance.
• History of gastric surgery, etc.
• Abnormality or clinical lab test results at Screening that is considered clinical significant by the investigator or the medical monitor.
• Gastroenteritis within 1 week before Day 1.
• Acute illness that could pose a threat or harm to the subject or interfere with laboratory test results or interpretation of study data.
• Donated blood within a 4 week period before Day 1.
• Positive for Hep B, C or HIV-1, HIV=2, or positive results at Screening for hepatitis B surface antigen (HBsAG), HCV antibody, or HIV-1 or HIV-2 antibodies
• Medication-related exclusions

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; EDP-322 v. Placebo	Drug: EDP-322

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The study objective was to determine the safety, tolerability and pharmacokinetics of multiple oral doses of EDP-322 in healthy volunteers.	Subjects received single doses of the study drug administered QD on Days 1 through 7, with follow-up through Day 11, and as needed.

Collaborators and Investigators

• Sponsor: Enanta Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: October 5, 2009
• First Submitted That Met QC Criteria: October 5, 2009
• First Posted (Estimate): October 6, 2009

Study Record Updates

• Last Update Posted (Estimate): October 8, 2009
• Last Update Submitted That Met QC Criteria: October 7, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: EDP-322-07-002