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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Kitashinagawa, Shinagawa-ku, Tokyo, 141-0001 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease, Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT00684710
Pfizer
Completed
Study Evaluating the Safety, Tolerability and Activity of One Dose of PAZ-417 Given to Healthy Japanese Subjects

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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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Alzheimer Disease
  • Healthy
  • Drug: PAZ-417
  • Drug: Placebo
  • Experimental: PAZ-417
    Intervention: Drug: PAZ-417
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
August 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
20 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00684710
3186A1-101
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
January 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

Clini[email protected]



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