Status:
COMPLETED
Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborating Sponsors:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the effects of multiple doses of Gemfibrozil on the plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to assess the safety a...
Eligibility Criteria
Inclusion
- Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg.
- Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.
Exclusion
- Presence or history of any disorder that may prevent the successful completion of the study.
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00966966
Start Date
September 1 2009
End Date
December 1 2009
Last Update
August 20 2010
Active Locations (1)
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1
Pfizer Investigational Site
Utrecht, Netherlands, 3584 CJ