Multiple Ascending-Dose Study of EDP 322 in Healthy Adult Volunteers

Completed · Phase 1

Conditions studied: MRSA, SSTI

In brief

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.

Key facts

Study ID

NCT00990145

Run by

Enanta Pharmaceuticals, Inc

People needed

52

Starts

2008-11-01

Expected to finish

2009-09-01

Last updated by the study team

2009-10-08

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.