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Study Evaluating FXR-450 in Healthy Japanese Men

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Tokyo, , 171-0014 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men aged 20 to 45 years.

- Healthy as determined by the investigator.

- Nonsmoker or smoker of fewer than 10 cigarettes per day.

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

- 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).

NCT00509756
Pfizer
Terminated
Study Evaluating FXR-450 in Healthy Japanese Men

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Study Evaluating FXR-450 in Healthy Japanese Men
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of FXR-450 Administered Orally to Healthy Japanese Male Subjects
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Healthy
  • Drug: FXR-450
    capsule, single oral doses from 10 mg to 450 mg
  • Drug: Placebo
    capsule similar to active drug
  • Active Comparator: 1
    Drug: FXR-450
    Intervention: Drug: FXR-450
  • Placebo Comparator: 2
    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.
 
Terminated
56
February 2008
February 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men aged 20 to 45 years.
  • Healthy as determined by the investigator.
  • Nonsmoker or smoker of fewer than 10 cigarettes per day.

Exclusion Criteria:

  • 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).
Sexes Eligible for Study: Male
20 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00509756
3213A1-1002
Not Provided
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
October 2010

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.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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