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

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ClinicalTrials.gov Identifier: NCT00990145
Recruitment Status : Completed
First Posted : October 6, 2009
Last Update Posted : October 8, 2009
Sponsor:
Information provided by:
Enanta Pharmaceuticals

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 in healthy adult volunteers.

Condition or disease Intervention/treatment Phase
MRSA, SSTI Drug: EDP-322 Phase 1

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 once daily (QD) for 7 days under fed conditions. Multiple oral doses of EDP 322 ranging from 200 to 800 mg were safe and generally well tolerated by the healthy male and female subjects in this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Safety, Tolerability, and Pharmacokinetics Study of EDP-322 in Healthy Adult Volunteers
Study Start Date : November 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: Intervention
EDP-322 v. Placebo
Drug: EDP-322



Primary Outcome Measures :
  1. The study objective was to determine the safety, tolerability and pharmacokinetics of multiple oral doses of EDP-322 in healthy volunteers. [ Time Frame: Subjects received single doses of the study drug administered QD on Days 1 through 7, with follow-up through Day 11, and as needed. ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990145


Locations
United States, Texas
PPD Phase I Unit
Austin, Texas, United States
Sponsors and Collaborators
Enanta Pharmaceuticals

Responsible Party: Maria T. Madison, Sc.D., Enanta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00990145     History of Changes
Other Study ID Numbers: EDP-322-07-002
First Posted: October 6, 2009    Key Record Dates
Last Update Posted: October 8, 2009
Last Verified: October 2009