Status:
COMPLETED
Study Evaluating Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose of SAM-531
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Alzheimer Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 subjects
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00726115
Start Date
August 1 2008
End Date
February 1 2009
Last Update
July 30 2009
Active Locations (1)
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1
Rueil-Malmaison, France, 92502