Study Evaluating FXR-450 in Healthy Japanese Men

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Wyeth

Status and phase

Terminated
Phase 1

Conditions

Healthy

Treatments

Drug: FXR-450
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00509756
3213A1-1002

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

56 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Description:
Drug: FXR-450
Treatment:
Drug: FXR-450
2
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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