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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00382668
First received: September 26, 2006
Last updated: April 13, 2011
Last verified: April 2011
  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

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Biospecimen Retention:   Samples With DNA

Whole Blood


Estimated Enrollment: 40
Study Start Date: October 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: Dasatinib
Tablets, Oral, 50 mg, once daily, for one day
Other Name: Sprycel
B Drug: Dasatinib
Tablets, Oral, 20 mg, once daily for one day
Other Name: Sprycel
C Drug: Dasatinib
Tablets, Oral, 70 mg, once daily for one day
Other Name: Sprycel

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
University Of Miami
Miami, Florida, United States, 33136
Comprehensive Phase One
Miramar, Florida, United States, 33025
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
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 Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00382668     History of Changes
Other Study ID Numbers: CA180-051
Study First Received: September 26, 2006
Last Updated: April 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
hepatically impaired

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014