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

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.

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.

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).