Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Enanta Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00989872
First received: October 5, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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. EDP-322 has a benefit to risk profile that supports testing in target patient populations.


Condition Intervention Phase
Skin and Soft Tissue Infections
Methicillin-resistant Staphylococcus Aureus
Drug: EDP-322
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-Controlled, Ascending Single-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 objectives included determining the safety, tolerability and pharmacokinetics of single oral doses of EDP-322 in healthy adult volunteers

Enrollment: 67
  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 [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 Criteria:

  • 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...
  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: NCT00989872

Locations
United States, Texas
PPD Phase I Unit
Austin, Texas, United States
Sponsors and Collaborators
Enanta Pharmaceuticals
Investigators
Principal Investigator: Thomas L Hunt, MD, PhD PPD Phase I Unit
  More Information

No publications provided

Responsible Party: Maria T. Madison, Dir. Clinical Operations, Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00989872     History of Changes
Other Study ID Numbers: EDP-322-007-001
Study First Received: October 5, 2009
Last Updated: October 5, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Enanta Pharmaceuticals:
Macrolides
Antibiotics
Safety
Tolerability
Pharmacokinetics
Phase I
MRSA/SSTI

Additional relevant MeSH terms:
Soft Tissue Infections
Staphylococcal Infections
Infection
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 01, 2014