A Study of Dasatinib to See How Liver Impaired and Healthy Subjects Process and React to the Study Drug

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to evaluate how a person with liver impairment processes and reacts to the study drug. Information about any side effects that may occur will also be collected.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Dasatinib

Criteria

Inclusion Criteria - All subjects:

• Male and females ≥18 years old

• Women must be of non-childbearing potential

• Adequate hematologic and renal function

• BMI 18-35 kg/m2

Inclusion Criteria - Liver Impaired subjects:

• Subjects must have stable liver impairment diagnosed with standard classification - Child Pugh

Exclusion Criteria - All subjects:

• Inability to swallow or absorb oral medication

• Uncontrolled medical disorder or infection

• Use of CYP3A4 inhibitors/inducers or drugs with risk of Torsades de Pointes

• Uncontrolled or Significant cardiovascular disease

• Any significant bleeding disorder

• Female subjects of childbearing potential

• Male subjects unwilling to use an effective method of contraception throughout the conduct of the study and for 2 months thereafter