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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00519298

Enrollment

Registered

2007-08-22

Start date

2007-10-31

Completion date

2008-03-31

Last updated

2008-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult, Healthy

Keywords

Alzheimer Disease

Brief summary

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

Interventions

DRUGSAM-531

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

OTHERplacebo

placebo

DRUGDonepezil

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Evaluation of the pharmacologic effect of SAM-531 on sleep EEG in healthy subjects	4 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026