Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered
- Registration Number
- NCT00966966
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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 and tolerability of co-administration of SAM-531 and Gemfibrozil.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 SAM-531 and gemfibrozil SAM-531_gemfibrozil
- Primary Outcome Measures
Name Time Method Maximum plasma concentration (Cmax) 24 days Time to maximum plasma concentration (tmax) 24 days Area under the concentration-time curve (AUC) 24 days
- Secondary Outcome Measures
Name Time Method Safety as measured by adverse event monitoring, ECG, vital signs, and laboratory tests 24 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇳🇱Utrecht, Netherlands