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

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ClinicalTrials.gov Identifier: NCT00382668
Recruitment Status : Completed
First Posted : September 29, 2006
Last Update Posted : April 14, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment
Liver Diseases Drug: Dasatinib

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Single-Dose Pharmacokinetics of Dasatinib in Subjects With Hepatic Impairment Compared to Healthy Adult Subjects
Study Start Date : October 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Dasatinib

Group/Cohort Intervention/treatment
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




Biospecimen Retention:   Samples With DNA
Whole Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00382668     History of Changes
Other Study ID Numbers: CA180-051
First Posted: September 29, 2006    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: April 2011

Keywords provided by Bristol-Myers Squibb:
hepatically impaired

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