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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

October 5, 2009
October 5, 2009
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The study objectives included determining the safety, tolerability and pharmacokinetics of single oral doses of EDP-322 in healthy adult volunteers
Same as current
No Changes Posted
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Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers
A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Safety, Tolerability, and Pharmacokinetics Study of EDP-322 in Healthy Adult Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Skin and Soft Tissue Infections
  • Methicillin-resistant Staphylococcus Aureus
Drug: EDP-322
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
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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...
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00989872
EDP-322-007-001
Not Provided
Maria T. Madison, Dir. Clinical Operations, Enanta Pharmaceuticals
Enanta Pharmaceuticals
Not Provided
Principal Investigator: Thomas L Hunt, MD, PhD PPD Phase I Unit
Enanta Pharmaceuticals
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP