Study Evaluating FXR-450 in Healthy Japanese Men

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00509756

Enrollment

Registered

2007-07-31

Start date

2007-11-30

Completion date

2008-02-29

Last updated

2010-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

healthy subjects

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.

Interventions

DRUGFXR-450

capsule, single oral doses from 10 mg to 450 mg

DRUGPlacebo

capsule similar to active drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame
The primary outcome is safety and tolerability.	4 days

Secondary

Measure	Time frame
Pharmacokinetics	4 days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026