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

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ClinicalTrials.gov Identifier: NCT00519298
Recruitment Status : Completed
First Posted : August 22, 2007
Last Update Posted : April 22, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Healthy Adult Drug: SAM-531 Other: placebo Drug: Donepezil Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : October 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Evaluation of the pharmacologic effect of SAM-531 on sleep EEG in healthy subjects [ Time Frame: 4 months ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519298


Locations
France
Rouffach, France, 68250
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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00519298     History of Changes
Other Study ID Numbers: 3193A1-1110
First Posted: August 22, 2007    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 2008

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
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents