Study Evaluating FXR-450 in Healthy Japanese Men

Overview

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.

Full Title of Study: “Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of FXR-450 Administered Orally to Healthy Japanese Male Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2008

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.

Interventions

  • Drug: FXR-450
    • capsule, single oral doses from 10 mg to 450 mg
  • Drug: Placebo
    • capsule similar to active drug

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Drug: FXR-450
  • Placebo Comparator: 2
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • The primary outcome is safety and tolerability.
    • Time Frame: 4 days

Secondary Measures

  • Pharmacokinetics
    • Time Frame: 4 days

Participating in This Clinical Trial

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).

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Wyeth is now a wholly owned subsidiary of Pfizer
  • Provider of Information About this Clinical Study
    • Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
  • Overall Official(s)
    • Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer

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