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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: |
NCT00474552 |
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Date of registration:
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15/05/2007 |
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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 the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315
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Scientific title:
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An Ascending Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 Administered Orally to Healthy Young Adult and Elderly Subjects |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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56 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00474552 |
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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: Single Group 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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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For France: infomedfrance@wyeth.com |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Young healthy subjects:
- Men and women of nonchildbearing potential (WONCBP) aged 18 to 45 years inclusive on
study day 1.
- Body mass index (BMI) in the range of 18 to 30 kg/m2 and body weight greater than or
equal to 50 kg and body weight greater than or equal to 50 kg.
Elderly Healthy subjects:
- Men or women aged 65 years and above as of study day 1.
- BMI in the range of 18 to 30 kg/m2 and body weight greater than or equal to 45 kg and
body weight greater than or equal to 45 kg.
Exclusion Criteria:
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal,
endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric
disease.
- History of any clinically important drug allergy.
Age minimum:
18 Years
Age maximum:
N/A
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: SAM-315
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Primary Outcome(s)
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safety, tolerability and PK
[Time Frame: 10 months]
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Secondary ID(s)
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3182A1-101
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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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