Overview

Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered

Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborator:
Pfizer
Treatments:
Gemfibrozil
Criteria
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.