Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers

Phase 1

Completed

• Conditions: Skin and Soft Tissue Infections; Methicillin-resistant Staphylococcus Aureus

• Registration Number: NCT00989872
• Lead Sponsor: Enanta Pharmaceuticals, Inc

Brief Summary

This was a randomized, double-blind, placebo-controlled, ascending single dose safety, tolerability, and pharmacokinetic study of orally administered EDP-322. This study was conducted at a single site. EDP-322 has a benefit to risk profile that supports testing in target patient populations.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-10
• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-05
• Last Update Submitted: 2009-10-05
• Study First Posted: 2009-10-06
• Last Update Posted: 2009-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Healthy adult males or females [if documentation existed that they were surgically sterilized].
• Were in good general health as determined by medical history, physical exam and clinical laboratory tests, and without evidence of clinically significant abnormality, in the opinion of the Investigator and Medical Monitor.
• The resting 12-lead ECG obtained at Screening shows no clinically significant abnormality and a QTc (Bazett's correction) <450 msec.
• Weight less than 132 pounds (60kg) with BMI between 18-32 kg/m3, inclusive.
• Subject has read, understood, and signed the written informed consent form.

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Exclusion Criteria

• History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances.
• History of gastric surgery, vagotomy, bowel resection, or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption.
• Any abnormal or screening clinical lab test results...
• Medication Related exclusions...
• Lifestyle related...

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The study objectives included determining the safety, tolerability and pharmacokinetics of single oral doses of EDP-322 in healthy adult volunteers

Trial Locations

Locations (1)

PPD Phase I Unit; 🇺🇸 Austin, Texas, United States