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

Wyeth is now a wholly owned subsidiary of Pfizer0 sites56 target enrollmentNovember 2007

ConditionsHealthy

InterventionsFXR-450 Placebo

DrugsFXR-450 Placebo

Overview

Phase: Phase 1
Intervention: FXR-450
Conditions: Healthy
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 56
Primary Endpoint: The primary outcome is safety and tolerability.
Status: Terminated
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

February 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

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).