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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00382668

Enrollment

Registered

2006-09-29

Start date

2006-10-31

Completion date

2007-08-31

Last updated

2011-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Diseases

Keywords

hepatically impaired

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.

Interventions

DRUGDasatinib

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026