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

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00519298

First received: August 20, 2007

Last updated: April 21, 2008

Last verified: April 2008

Purpose

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

Condition	Intervention	Phase
Healthy Adult	Drug: SAM-531 Other: placebo Drug: Donepezil	Phase 1

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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

Drug Information available for: Donepezil hydrochloride Donepezil

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

Evaluation of the pharmacologic effect of SAM-531 on sleep EEG in healthy subjects [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	October 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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
Placebo Comparator: 2	Other: placebo placebo
Active Comparator: 3	Drug: Donepezil dosage form: 5 mg encapsulated tablets one single dose of 5 mg.

Eligibility

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519298

Locations

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:	Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:	Trial Manager	For France: infomedfrance@wyeth.com

More Information

No publications provided

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00519298 History of Changes
Other Study ID Numbers:	3193A1-1110
Study First Received:	August 20, 2007
Last Updated:	April 21, 2008
Health Authority:	United States: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Institutional Ethical Committee

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Alzheimer Disease

Additional relevant MeSH terms:

Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents

Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013