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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00726115 |
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Date of registration:
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28/07/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study Evaluating Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose of SAM-531
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Scientific title:
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Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Dose of SAM-531 Administered Orally To Healthy Young and Elderly Subjects |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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56 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00726115 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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France
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alzheimer Disease
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Intervention(s)
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Drug: placebo
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Drug: SAM-531
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Primary Outcome(s)
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Pharmacokinetics, routine Lab tests, Vital signs, ECG
[Time Frame: 29 days]
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Secondary ID(s)
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3193A1-1111
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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