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

Completed · Phase 1

Conditions studied: Skin and Soft Tissue Infections, Methicillin-resistant Staphylococcus Aureus

In brief

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.

Key facts

Study ID

NCT00989872

Run by

Enanta Pharmaceuticals, Inc

People needed

67

Last updated by the study team

2009-10-06

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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...

Where it is running

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

Full record on ClinicalTrials.gov

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