Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00382668
Other study ID # CA180-051
Secondary ID
Status Completed
Phase N/A
First received September 26, 2006
Last updated April 13, 2011
Start date October 2006
Est. completion date August 2007

Study information

Verified date April 2011
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Dasatinib
Tablets, Oral, 50 mg, once daily, for one day
Dasatinib
Tablets, Oral, 20 mg, once daily for one day
Dasatinib
Tablets, Oral, 70 mg, once daily for one day

Locations

Country Name City State
United States New Orleans Center For Clinical Research Knoxville Tennessee
United States University Of Miami Miami Florida
United States Comprehensive Phase One Miramar Florida
United States Orlando Clinical Research Center Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Recruiting NCT05255042 - Tissue Models for Liver Disease
Completed NCT04473482 - Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial N/A
Not yet recruiting NCT05120557 - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH N/A
Completed NCT02917408 - Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Recruiting NCT03773887 - Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease N/A
Recruiting NCT00345930 - DILIN - Prospective Study
Completed NCT00148031 - Improving Hepatitis C Treatment in Injection Drug Users Phase 4
Terminated NCT00031135 - Total Parenteral Nutrition-Associated Liver Disease Phase 2
Completed NCT00005305 - Hepatitis Delta Infections in Hemophiliacs N/A
Completed NCT00005304 - Delta Hepatitis and Liver Disease in Hemophiliacs
Completed NCT00222664 - Qidong Hepatitis B Intervention Study Phase 4
Recruiting NCT06195917 - Robotic-assisted Percutaneous Transhepatic Puncture N/A
Recruiting NCT04551742 - Social & Contextual Impact on Children Undergoing Liver Transplantation
Completed NCT04782050 - Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation N/A
Completed NCT03614039 - Effect of Probiotic and Smectite Gel on NAFLD N/A
Recruiting NCT04518852 - TACE, Sorafenib and PD-1 Monoclonal Antibody in the Treatment of HCC Phase 2
Recruiting NCT05499585 - Treating Pediatric NAFLD With Nutrition N/A
Terminated NCT03396705 - Liver Regeneration
Completed NCT04341012 - Breath Analysis Based Disease Biomarkers of COVID-19 and Other Diseases
Recruiting NCT05733832 - A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease N/A