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CompletedPhase 1

Study Evaluating The Potential Interaction Between Verapamil Immediate Release And SAM-531 When Co-Administered

An Open-label, Nonrandomized Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Verapamil Immediate Release (IR) and a Single Dose of SAM-531 When Co-administered Orally to Healthy Young Adult Subjects

Asset

SAM-531

Listed sites

1

Recruiting sites

-

Enrollment

14

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-55

Primary endpoint

•Blood samples

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 ID3193A1-1112
NCT IDNCT00745576

Timeline

Milestones

Study first posted2008-09-03estimated
Study start2008-10 (month precision)
Primary completion2008-12actual (month precision)
Study completion2008-12actual (month precision)
Last update posted2010-02-08estimated

Assets

Drug assets

SAM-531

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg.

2. Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings

Exclusion criteria

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

2. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

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.

Coverage by outcome category

Safety / tolerability / PK
1
Other (unclassified)
1

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Safety based on supine vital signs evaluations, 12-lead ECGs and routine lab tests

Time frame:7 weeks

descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

blood samples

Time frame:7 weeks

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.