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Study Evaluating FXR-450 in Healthy Japanese Men

NCT ID: NCT00509756

Last Updated: 2010-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-02-29

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Drug: FXR-450

Group Type ACTIVE_COMPARATOR

FXR-450

Intervention Type DRUG

capsule, single oral doses from 10 mg to 450 mg

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

capsule similar to active drug

Interventions

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FXR-450

capsule, single oral doses from 10 mg to 450 mg

Intervention Type DRUG

Placebo

capsule similar to active drug

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Tokyo, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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3213A1-1002

Identifier Type: -

Identifier Source: org_study_id