NCT00519298

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy
• Adult

Interventions

Type	Name	Description
DRUG	SAM-531	dosage form : 0.5 mg and 5 mg capsules 3 different single doses : 1 mg, 3mg and 10 mg of SAM-531
OTHER	placebo	placebo
DRUG	Donepezil	dosage form: 5 mg encapsulated tablets one single dose of 5 mg.

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2007-08-22
• Last updated: 2008-04-22

Locations

1 site across 1 country: France