- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00989872
Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers
October 5, 2009 updated by: Enanta Pharmaceuticals, Inc
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Austin, Texas, United States
- PPD Phase I Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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...
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas L Hunt, MD, PhD, PPD Phase I Unit
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 5, 2009
First Submitted That Met QC Criteria
October 5, 2009
First Posted (Estimate)
October 6, 2009
Study Record Updates
Last Update Posted (Estimate)
October 6, 2009
Last Update Submitted That Met QC Criteria
October 5, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EDP-322-007-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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