CompletedPhase 1

Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Japanese Males

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

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Asset

SAM-531

Listed sites

Recruiting sites

Enrollment

Study population

Alzheimer’s disease

Key I/E criteria

•Age 20-45•Male

Primary endpoint

•Safety and tolerability

Identifiers

Registered as

Org study ID3193A1-101

NCT IDNCT00479297

Timeline

Milestones

Study start2006-05 (month precision)

Primary completion2007-02actual (month precision)

Study completion2007-02actual (month precision)

Study first posted2007-05-28estimated

Last update posted2009-08-07estimated

Assets

Drug assets

SAM-531

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age20 Years

Maximum age45 Years

SexMale

Healthy volunteersNot accepted

Inclusion criteria

•Men aged 20 to 45 years (inclusive) at the time of getting informed consent.

•Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥50 kg (BMI = [weight (kg)]/[height (m)2).

•Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ECG). Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine levels must be within the upper limit of normal for eligibility

Exclusion criteria

•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, digital 12-lead ECGs, or clinical laboratory test results.

•Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a grapefruit-containing product is prohibited from 72 hours before study day 1.

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

descriptive

Secondary/protocol endpoint

Pharmacokinetics and pharmacodynamics

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.