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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Dasatinib

Intervention Type DRUG

Tablets, Oral, 50 mg, once daily, for one day

B

Dasatinib

Intervention Type DRUG

Tablets, Oral, 20 mg, once daily for one day

C

Dasatinib

Intervention Type DRUG

Tablets, Oral, 70 mg, once daily for one day

Interventions

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Dasatinib

Tablets, Oral, 50 mg, once daily, for one day

Intervention Type DRUG

Dasatinib

Tablets, Oral, 20 mg, once daily for one day

Intervention Type DRUG

Dasatinib

Tablets, Oral, 70 mg, once daily for one day

Intervention Type DRUG

Other Intervention Names

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Sprycel Sprycel Sprycel

Eligibility Criteria

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Inclusion Criteria

* Male and females ≥18 years old
* Women must be of non-childbearing potential
* Adequate hematologic and renal function
* BMI 18-35 kg/m2

* Subjects must have stable liver impairment diagnosed with standard classification - Child Pugh

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes