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
- Men aged 20 to 45 years.
- Healthy as determined by the investigator.
- Nonsmoker or smoker of fewer than 10 cigarettes per day.
- A history or active presence of clinically important medical disease.
- Any surgical or medical condition that may interfere with the absorption,
distribution, metabolism, or excretion of the test article (e.g., resection of liver,
kidney, gallbladder, or gastrointestinal tract).
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating FXR-450 in Healthy Japanese Men | |||
Official Title ICMJE | Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of FXR-450 Administered Orally to Healthy Japanese Male Subjects | |||
Brief Summary | The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of a single dose of FXR-450 in healthy Japanese men. | |||
Detailed Description | This study was terminated on May 2008. The reason for termination was due to pharmacokinetics issues. The decision to terminate was not due to safety and tolerability. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | Terminated | |||
Actual Enrollment ICMJE | 56 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | February 2008 | |||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 45 Years (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 | NCT00509756 | |||
Other Study ID Numbers ICMJE | 3213A1-1002 | |||
Has Data Monitoring Committee | Not Provided | |||
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 |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | October 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |