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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519298
• Other study ID #: 3193A1-1110
• Status: Completed
• Phase: Phase 1
• First received: August 20, 2007
• Last updated: April 21, 2008
• Start date: October 2007
• Est. completion date: March 2008

Study information

• Verified date: April 2008
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Adult
• Healthy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the pharmacologic effect of SAM-531 on sleep EEG in healthy subjects		4 months	No