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

This study has been completed.

First Received: September 26, 2006 Last Updated: June 27, 2008 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00382668

Purpose

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.

Condition	Intervention
Liver Diseases	Drug: Dasatinib

MedlinePlus related topics: Liver Diseases

Drug Information available for: Dasatinib

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Single-Dose Pharmacokinetics of Dasatinib in Subjects With Hepatic Impairment Compared to Healthy Adult Subjects

Further study details as provided by Bristol-Myers Squibb:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole Blood

Estimated Enrollment:	40
Study Start Date:	October 2006
Study Completion Date:	August 2007

Groups/Cohorts	Assigned Interventions
A	Drug: Dasatinib Tablets, Oral, 50 mg, once daily, for one day
B	Drug: Dasatinib Tablets, Oral, 20 mg, once daily for one day
C	Drug: Dasatinib Tablets, Oral, 70 mg, once daily for one day

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Male and Female Subjects with hepatic insufficiency conforming to Child-Pugh classification B

Male and Female Subjects with hepatic insufficiency conforming to Child-Pugh classification C

Healthy Control subjects in good health

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382668

Locations

United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Comprehensive Phase One
Miramar, Florida, United States, 33025
University Of Miami
Miami, Florida, United States, 33136
United States, Tennessee
New Orleans Center For Clinical Research
Knoxville, Tennessee, United States, 37920

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA180-051
Study First Received:	September 26, 2006
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00382668 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

hepatically impaired

Study placed in the following topic categories:

Liver Diseases
Digestive System Diseases
Dasatinib
Healthy
Protein Kinase Inhibitors

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Dasatinib

Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009