Study Evaluating Effects of SAM-531 on Sleep Electroencephalogram (EEG) and Quantitative Wake EEG in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy; Adult
• Interventions: Other: placebo; Drug: SAM-531; Drug: Donepezil

• Registration Number: NCT00519298
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

Primary: To evaluate the pharmacologic effect of single doses of SAM-531 on sleep EEG in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-20
• Study First Submitted QC: 2007-08-21
• Study First Posted: 2007-08-22
• Study Start: 2007-10
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-21
• Last Update Posted: 2008-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	SAM-531	-
3	Donepezil	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the pharmacologic effect of SAM-531 on sleep EEG in healthy subjects	4 months