NCT00519298
Completed
Phase 1
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
Wyeth is now a wholly owned subsidiary of Pfizer0 sites25 target enrollmentStarted: October 2007Last updated:
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 25
- Primary Endpoint
- Evaluation of the pharmacologic effect of SAM-531 on sleep EEG in healthy subjects
Overview
Brief Summary
Primary: To evaluate the pharmacologic effect of single doses of SAM-531 on sleep EEG in healthy subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men or women of non-childbearing potential aged 18 to 50 years inclusive on study day
- •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.
Arms & Interventions
1
Experimental
Intervention: SAM-531 (Drug)
2
Placebo Comparator
Intervention: placebo (Other)
3
Active Comparator
Intervention: Donepezil (Drug)
Outcomes
Primary Outcomes
Evaluation of the pharmacologic effect of SAM-531 on sleep EEG in healthy subjects
Time Frame: 4 months
Secondary Outcomes
No secondary outcomes reported
Investigators
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