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

This study has been completed.
Sponsor:
Information provided by:
Enanta Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00990145
First received: October 5, 2009
Last updated: October 7, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
MRSA, SSTI
Drug: EDP-322
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Masking: Double Blind (Subject, 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

Further study details as provided by Enanta Pharmaceuticals:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: November 2008
Study Completion Date: September 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
EDP-322 v. Placebo
Drug: 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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990145

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

No publications provided

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
Study First Received: October 5, 2009
Last Updated: October 7, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014