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

August 20, 2007
April 21, 2008
October 2007
March 2008   (final data collection date for primary outcome measure)
Evaluation of the pharmacologic effect of SAM-531 on sleep EEG in healthy subjects [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Evaluation of the pharmacologic effect of SAM-531 on sleep EEG in healthy subjects
Complete list of historical versions of study NCT00519298 on ClinicalTrials.gov Archive Site
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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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
  • Healthy
  • Adult
  • 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.
  • Experimental: 1
    Intervention: Drug: SAM-531
  • Placebo Comparator: 2
    Intervention: Other: placebo
  • Active Comparator: 3
    Intervention: Drug: Donepezil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00519298
3193A1-1110
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For France: infomedfrance@wyeth.com
Wyeth is now a wholly owned subsidiary of Pfizer
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP