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
1 other identifier
interventional
25
1 country
1
Brief Summary
Primary: To evaluate the pharmacologic effect of single doses of SAM-531 on sleep EEG in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Oct 2007
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2007
CompletedFirst Posted
Study publicly available on registry
August 22, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedApril 22, 2008
April 1, 2008
5 months
August 20, 2007
April 21, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of the pharmacologic effect of SAM-531 on sleep EEG in healthy subjects
4 months
Study Arms (3)
1
EXPERIMENTAL2
PLACEBO COMPARATOR3
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Rouffach, 68250, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
- PRINCIPAL INVESTIGATOR
Trial Manager
For France: infomedfrance@wyeth.com
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 20, 2007
First Posted
August 22, 2007
Study Start
October 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
April 22, 2008
Record last verified: 2008-04