Study Evaluating Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose of SAM-531
Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Dose of SAM-531 Administered Orally To Healthy Young and Elderly Subjects
1 other identifier
interventional
56
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 alzheimer-disease
Started Aug 2008
Shorter than P25 for phase_1 alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2008
CompletedFirst Posted
Study publicly available on registry
July 31, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedJuly 30, 2009
July 1, 2009
6 months
July 28, 2008
July 29, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics, routine Lab tests, Vital signs, ECG
29 days
Study Arms (2)
1
PLACEBO COMPARATORarm placebo
2
EXPERIMENTALarm drug
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Rueil-Malmaison, 92502, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 28, 2008
First Posted
July 31, 2008
Study Start
August 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
July 30, 2009
Record last verified: 2009-07