ClinicalTrials.gg
Sign In
TerminatedNCT00509756Updated Oct 22, 2010

Study Evaluating FXR-450 in Healthy Japanese Men

A Phase 1 interventional study of FXR-450 and Placebo in Healthy, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Terminated at 1 site in Japan. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-10-22.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer (part of Pfizer) · Phase 1 and Interventional

Why this study was terminated
Please see termination statement in the detailed description.
Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • healthy subjects
03

In context

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 484 studies on the registry; none are open to participants now.

First submitted before Wyeth became part of Pfizer.

Browse Wyeth studies →All Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Active comparator
    1

    Drug: FXR-450

    Drug: FXR-450

  • Placebo comparator
    2

    Placebo

    Drug: Placebo

Interventions

  • DrugFXR-450

    capsule, single oral doses from 10 mg to 450 mg

  • DrugPlacebo

    capsule similar to active drug

06

What researchers measure

Primary outcomes

  1. The primary outcome is safety and tolerability.

    Time frame: 4 days

Secondary outcomes

  1. Pharmacokinetics

    Time frame: 4 days

07

Study locations

1 site
  • Tokyo, Tokyo 171-0014, Japan
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2007, a primary completion of Feb 2008 and a completion of Feb 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2007
First posted
Jul 31, 2007
Start
Nov 2007
Primary completionActual
Feb 2008
CompletionActual
Feb 2008
Last update
Oct 22, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 22, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00509756
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Jul 31, 2007
Start date
Nov 2007
Primary completion
Feb 2008
Completion
Feb 2008
Last update
Oct 22, 2010

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Wyeth is now a wholly owned subsidiary of Pfizer →

Start the discussion