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Study Evaluating FXR-450 in Healthy Japanese Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00509756
Recruitment Status : Terminated (Please see termination statement in the detailed description.)
First Posted : July 31, 2007
Last Update Posted : October 22, 2010
Sponsor:
Information provided by:

July 30, 2007
July 31, 2007
October 22, 2010
November 2007
February 2008   (Final data collection date for primary outcome measure)
The primary outcome is safety and tolerability. [ Time Frame: 4 days ]
The primary outcome is safety and tolerability.
Complete list of historical versions of study NCT00509756 on ClinicalTrials.gov Archive Site
Pharmacokinetics [ Time Frame: 4 days ]
Not Provided
Not Provided
Not Provided
 
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