Study Evaluating FXR-450 in Healthy Japanese Men

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: FXR-450; Drug: Placebo

• Registration Number: NCT00509756
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2007-07-30
• Study First Submitted QC: 2007-07-30
• Study First Posted: 2007-07-31
• Study Start: 2007-11
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-21
• Last Update Posted: 2010-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 56

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	FXR-450	Drug: FXR-450
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
The primary outcome is safety and tolerability.	4 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	4 days