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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00684710

Enrollment

Registered

2008-05-28

Start date

2008-04-30

Completion date

2008-08-31

Last updated

2009-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Healthy

Keywords

Alzheimer Disease

Brief summary

This study will provide an initial assessment of the safety, tolerability, and pharmacokinetics (PK) of PAZ-417 after administration of ascending single oral doses to healthy young Japanese male and healthy elderly Japanese male subjects.

Interventions

DRUGPAZ-417

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety and Tolerability	3 months

Secondary

Measure	Time frame
Pharmacokinetics	3 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026