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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Donepezil

Criteria

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.