Status:
COMPLETED
Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers
Lead Sponsor:
Enanta Pharmaceuticals, Inc
Conditions:
Skin and Soft Tissue Infections
Methicillin-resistant Staphylococcus Aureus
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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...
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00989872
Last Update
October 6 2009
Active Locations (1)
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1
PPD Phase I Unit
Austin, Texas, United States