Study Evaluating FXR-450 in Healthy Japanese Men

Phase 1TerminatedNCT00509756

Wyeth is now a wholly owned subsidiary of Pfizer56 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

FXR-450DRUG

capsule, single oral doses from 10 mg to 450 mg

PlaceboDRUG

capsule similar to active drug

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Unnamed facility

Tokyo, Tokyo, Japan

Outcomes

Primary Outcomes

The primary outcome is safety and tolerability.

Time frame: 4 days

Secondary Outcomes

Pharmacokinetics

Time frame: 4 days

Data from ClinicalTrials.gov

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