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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00989872 |
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Date of registration:
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05/10/2009 |
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Primary sponsor: |
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Public title:
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Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers
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Scientific title:
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A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Safety, Tolerability, and Pharmacokinetics Study of EDP-322 in Healthy Adult Volunteers |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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67 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00989872 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Thomas L Hunt, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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PPD Phase I Unit |
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Key inclusion & exclusion criteria
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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...
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Methicillin-resistant Staphylococcus Aureus
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Skin and Soft Tissue Infections
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Intervention(s)
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Drug: EDP-322
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Primary Outcome(s)
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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
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Secondary ID(s)
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EDP-322-007-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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