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Completed

NCT Number: NCT00382668

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

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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Key information

Conditions

Liver Diseases Digestive System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Of Miami, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dasatinib

Drug

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

Other names: Sprycel

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 29, 2006
Registry last updated
Apr 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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