CClinicalTrials.gg
Sign In
CompletedNCT00519298Updated Apr 22, 2008

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

A Phase 1 interventional study of SAM-531 and placebo in Healthy and Adult, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 1 site in France. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-04-22.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy
  • Adult

Keywords

  • Alzheimer Disease
03

In context

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    1

    Drug: SAM-531

  • Placebo comparator
    2

    Other: placebo

  • Active comparator
    3

    Drug: Donepezil

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.

06

What researchers measure

Primary outcomes

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

    Time frame: 4 months

07

Study locations

1 site
  • Rouffach, 68250, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00519298
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Aug 22, 2007
Start date
Oct 2007
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Apr 22, 2008

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager
principal investigator · For France: infomedfrance@wyeth.com
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Start the discussion