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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684710
• Other study ID #: 3186A1-101
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2008
• Last updated: January 28, 2009
• Start date: April 2008
• Est. completion date: August 2008

Study information

• Verified date: January 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Healthy

Intervention

Drug:
• PAZ-417

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability		3 months	Yes
Secondary	Pharmacokinetics		3 months	No