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

Liver Diseases Clinical Trial

Official title:

Single-Dose Pharmacokinetics of Dasatinib in Subjects With Hepatic Impairment Compared to Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382668
• Other study ID #: CA180-051
• Status: Completed
• Phase: N/A
• First received: September 26, 2006
• Last updated: April 13, 2011
• Start date: October 2006
• Est. completion date: August 2007

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Drug:
• Dasatinib
Tablets, Oral, 50 mg, once daily, for one day
• Dasatinib
Tablets, Oral, 20 mg, once daily for one day
• Dasatinib
Tablets, Oral, 70 mg, once daily for one day

Locations

Country	Name	City	State
United States	New Orleans Center For Clinical Research	Knoxville	Tennessee
United States	University Of Miami	Miami	Florida
United States	Comprehensive Phase One	Miramar	Florida
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm