Study Evaluating the Safety, Tolerability and Activity of One Dose of PAZ-417 Given to Healthy Japanese Subjects
NCT00684710
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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).
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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- New York, New York
- Tokyo,
- Kitashinagawa, Shinagawa-ku, Tokyo
- 5-4-12, Kitashinagawa, Shinagawa-ku
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating the Safety, Tolerability and Activity of One Dose of PAZ-417 Given to Healthy Japanese Subjects | |||
Official Title ICMJE | 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 | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE | 56 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | August 2008 | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 20 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00684710 | |||
Other Study ID Numbers ICMJE | 3186A1-101 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | January 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |