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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy; Alzheimer Disease

Treatments: Drug: Placebo; Drug: PAZ-417

Study type: Interventional

Funder types: Industry

Identifiers

NCT00684710

3186A1-101

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: Male

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups, including a placebo group

PAZ-417

Experimental group

Treatment:

Drug: PAZ-417

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo