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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: |
NCT00519298 |
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Date of registration:
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20/08/2007 |
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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 Effects of SAM-531 on Sleep Electroencephalogram (EEG) and Quantitative Wake EEG in Healthy Subjects
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Scientific title:
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A Double-Blind, Placebo-Controlled, Balanced, 4-Way, Incomplete Block Design to Evaluate the Effects of a Single Administration of SAM-531 on Sleep Electroencephalogram (EEG) and Quantitative Wake EEG (qEEG) in Healthy Subjects |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00519298 |
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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: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
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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:
- Men or women of non-childbearing potential aged 18 to 50 years inclusive on study day
1.
- Body mass index in the range of 18 to 30 kg/m2 and body weight greater than or equal
to 50 kg.
- Healthy as determined by the investigator on the basis of medical history, physical
examination, clinical laboratory test results, vital sign measurements, and 12-lead
electrocardiogram.
Exclusion Criteria:
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal,
endocrine, immunologic, dermatologic, neurologic, hematologic, neurologic, or
psychiatric disease.
- Clinically significant abnormal standard EEG at screening.
- Consumption of any caffeine-containing products or alcoholic beverages within 48
hours before study day 1.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Adult
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Healthy
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Intervention(s)
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Drug: Donepezil
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Other: placebo
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Drug: SAM-531
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Primary Outcome(s)
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Evaluation of the pharmacologic effect of SAM-531 on sleep EEG in healthy subjects
[Time Frame: 4 months]
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Secondary ID(s)
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3193A1-1110
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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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