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Completed

NCT Number: NCT00519298

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

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

Completed

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Key information

Conditions

Healthy Adult Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rouffach, 68250, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAM-531

Drug

dosage form : 0.5 mg and 5 mg capsules 3 different single doses : 1 mg, 3mg and 10 mg of SAM-531

Placebo

Other

placebo

Donepezil

Drug

dosage form: 5 mg encapsulated tablets one single dose of 5 mg.

Primary outcomes

  1. Evaluation of the pharmacologic effect of SAM-531 on sleep EEG in healthy subjects

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 22, 2007
Registry last updated
Apr 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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