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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

Tracking Information
First Submitted Date  ICMJE August 20, 2007
First Posted Date  ICMJE August 22, 2007
Last Update Posted Date April 22, 2008
Study Start Date  ICMJE October 2007
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)		 Evaluation of the pharmacologic effect of SAM-531 on sleep EEG in healthy subjects [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2007)		 Evaluation of the pharmacologic effect of SAM-531 on sleep EEG in healthy subjects
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Effects of SAM-531 on Sleep Electroencephalogram (EEG) and Quantitative Wake EEG in Healthy Subjects
Official Title  ICMJE 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
Brief Summary Primary: To evaluate the pharmacologic effect of single doses of SAM-531 on sleep EEG in healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE
  • Healthy
  • Adult
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: SAM-531
  • Placebo Comparator: 2
    Intervention: Other: placebo
  • Active Comparator: 3
    Intervention: Drug: Donepezil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 19, 2007)		 25
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00519298
Other Study ID Numbers  ICMJE 3193A1-1110
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For France: infomedfrance@wyeth.com
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2008

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