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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Liver Diseases

Treatments: Drug: Dasatinib

Study type: Observational

Funder types: Industry

Identifiers

NCT00382668

CA180-051

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

40 participants in 3 patient groups

A

Treatment:

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

B

Treatment:

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

C

Treatment:

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib