Status:
COMPLETED
A Study of Dasatinib to See How Liver Impaired and Healthy Subjects Process and React to the Study Drug
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Liver Diseases
Eligibility:
All Genders
18-70 years
Brief 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00382668
Start Date
October 1 2006
End Date
August 1 2007
Last Update
April 14 2011
Active Locations (4)
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1
University Of Miami
Miami, Florida, United States, 33136
2
Comprehensive Phase One
Miramar, Florida, United States, 33025
3
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
4
New Orleans Center For Clinical Research
Knoxville, Tennessee, United States, 37920