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CompletedPhase 1

Study Evaluating the Safety, Tolerability and Activity of One Dose of PAZ-417 Given to Healthy Japanese Subjects

Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of PAZ 417 Administered Orally to Healthy Young Japanese Male and Healthy Elderly Japanese Male Subjects

Asset

PAZ-417

Listed sites

1

Recruiting sites

-

Enrollment

56

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 ID3186A1-101
NCT IDNCT00684710

Timeline

Milestones

Study start2008-04 (month precision)
Study first posted2008-05-28estimated
Primary completion2008-08actual (month precision)
Study completion2008-08actual (month precision)
Last update posted2009-01-30estimated

Assets

Drug assets

PAZ-417

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age20 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

1. Men aged 20 to 45 years inclusive (healthy young male subjects) and ≥65 years inclusive (healthy elderly male subjects)

2. Nonsmoker or smoker of fewer than 10 cigarettes per day.

3. 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

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

2. Subjects who are identified as being at risk for hypercoagulability

3. Use of any investigational or prescription drug within 30 days before test article administration

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:3 months

descriptive

Secondary/protocol endpoint

Pharmacokinetics

Time frame:3 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.