Status:
COMPLETED
Multiple Ascending-Dose Study of EDP 322 in Healthy Adult Volunteers
Lead Sponsor:
Enanta Pharmaceuticals, Inc
Conditions:
MRSA, SSTI
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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...
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 onc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00990145
Start Date
November 1 2008
End Date
September 1 2009
Last Update
October 8 2009
Active Locations (1)
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1
PPD Phase I Unit
Austin, Texas, United States