CompletedPhase 1

Study Evaluating How Quickly And To What Extent The 14-Carbon-SAM-531 Is Absorbed/Converted/Eliminated In Male Subjects

An Open-Label, Single-Dose, Nonrandomized Study Of The Mass Balance And Metabolic Disposition Of Orally Administered 14C-Labeled SAM-531 In Healthy Male Subjects

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Asset

SAM-531

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 18-50•Male

Primary endpoint

•Radioactivity measurements in blood, urine and feces

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 ID3193A1-1114

NCT IDNCT00906191

Timeline

Milestones

Study start2009-05 (month precision)

Study first posted2009-05-21estimated

Primary completion2009-08actual (month precision)

Study completion2009-08actual (month precision)

Last update posted2009-08-26estimated

Assets

Drug assets

SAM-531

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age50 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Men aged 18 to 50 years inclusive at screening

•Healthy as determined by the investigator on the basis of screening evaluations

Exclusion criteria

•Presence or history of any disorder that may prevent the successful completion of the study.

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

Endpoints (1)

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

1 endpoint

Primary/protocol endpoint

Radioactivity measurements in blood, urine and feces and pharmacokinetic parameters (Cmax, AUC, terminal elimination half life, total clearance and volume of distribution in the plasma ; urine clearance ; metabolite profiling in plasma, urine and feces.)

Time frame:15 days

concentration, 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.