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Trial record 1 of 1 for:    NCT00509756
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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. Identifier: NCT00509756
Recruitment Status : Terminated (Please see termination statement in the detailed description.)
First Posted : July 31, 2007
Last Update Posted : October 22, 2010
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: FXR-450 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of FXR-450 Administered Orally to Healthy Japanese Male Subjects
Study Start Date : November 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Arm Intervention/treatment
Active Comparator: 1
Drug: FXR-450
Drug: FXR-450
capsule, single oral doses from 10 mg to 450 mg

Placebo Comparator: 2
Drug: Placebo
capsule similar to active drug

Primary Outcome Measures :
  1. The primary outcome is safety and tolerability. [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00509756

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Tokyo, Japan, 171-0014
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

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Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth Identifier: NCT00509756    
Other Study ID Numbers: 3213A1-1002
First Posted: July 31, 2007    Key Record Dates
Last Update Posted: October 22, 2010
Last Verified: October 2010
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
healthy subjects