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

NCT ID: NCT00519298

Last Updated: 2008-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-03-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Adult

Keywords

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

SAM-531

Intervention Type DRUG

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

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo

3

Group Type ACTIVE_COMPARATOR

Donepezil

Intervention Type DRUG

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

Interventions

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SAM-531

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

Intervention Type DRUG

placebo

placebo

Intervention Type OTHER

Donepezil

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For France: [email protected]

Locations

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Rouffach, , France

Site Status

Countries

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France

Other Identifiers

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3193A1-1110

Identifier Type: -

Identifier Source: org_study_id