Overview
Study Evaluating Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose of SAM-531
Status:
Completed
Completed
Trial end date:
2009-02-01
2009-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The main objectives of this study is to assess the safety and tolerability of ascending single and multiple oral doses of SAM-531 in healthy subjectsPhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Criteria
Inclusion criteria:- Body mass index in the range of 18 to 30 kg/m2 and body weight greater than or equal
to 50 kg. Body weight for elderly subjects must be greater than or equal to 45 kg.
- 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.