Study Evaluating FXR-450 in Healthy Japanese Men

Wyeth

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: FXR-450

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