CompletedPhase 1

Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy

A Positron Emission Tomography Study to Assess the Level and Duration of Occupancy of Serotonin-1A Receptors Produced by Single Oral Doses of SRA-444 in Healthy Elderly Subjects and in Subjects With Alzheimer Disease

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Asset

SRA-444

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥60

Primary endpoints

•Safety and tolerability of ascending single oral doses of SRA-444 in healthy•To obtain PK profiles and determine the level

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 ID3197A1-1104

NCT IDNCT00499200

Timeline

Milestones

Study first posted2007-07-11estimated

Study start2007-10 (month precision)

Primary completion2008-06actual (month precision)

Study completion2008-06actual (month precision)

Last update posted2008-07-09estimated

Assets

Drug assets

SRA-444

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Men or women from 60 years of age at screening.

•Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)

Exclusion criteria

•History of drug abuse within 1 year 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.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

To assess the safety and tolerability of ascending single oral doses of SRA-444 in healthy elderly subjects and subjects with Alzheimer's disease

Time frame:after each dose group completion

descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

To obtain PK profiles and determine the level and duration of 5-HT1A RO of SRA-444 by PET

Time frame:1 month

ratio, 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.