CompletedPhase 1

Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531

An Ascending Multiple Dose Study of the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Japanese Young Male and Elderly Subjects

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Asset

SAM-531

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Age ≥20•Male

Primary endpoint

•Safety and tolerability

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID3193A1-1104

NCT IDNCT00479349

Timeline

Milestones

Study start2007-05 (month precision)

Study first posted2007-05-28estimated

Primary completion2008-01actual (month precision)

Study completion2008-01actual (month precision)

Last update posted2009-07-07estimated

Assets

Drug assets

SAM-531

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age20 Years

SexMale

Healthy volunteersAccepted

Eligibility criteria

•Men aged 20 to 45 years, inclusive, at screening.

•Elderly men or women aged 65 years and above as of screening.

•Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg.

Exclusion critereia

•Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

•Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be below the upper limit of normal at screening.

•Tobacco use or consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or carbonated beverages) or alcoholic beverages within 48 hours before study day 1 until the end of the inpatient confinement period.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Safety and tolerability

Time frame:9 months

descriptive

Secondary/protocol endpoint

Pharmacokinetics and pharmacodynamics

Time frame:9 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.