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

NCT ID: NCT00684710

Last Updated: 2009-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease Healthy

Keywords

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PAZ-417

Group Type EXPERIMENTAL

PAZ-417

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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PAZ-417

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Kitashinagawa, Shinagawa-ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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3186A1-101

Identifier Type: -

Identifier Source: org_study_id