NCT00382668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2006

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

April 14, 2011

Status Verified

April 1, 2011

Enrollment Period

10 months

First QC Date

September 26, 2006

Last Update Submit

April 13, 2011

Conditions

Liver Diseases

Keywords

hepatically impaired

Study Arms (3)

A

Drug: Dasatinib

B

Drug: Dasatinib

C

Drug: Dasatinib

Interventions

DasatinibDRUG

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

Also known as: Sprycel
A

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Of Miami

Miami, Florida, 33136, United States

Location

Comprehensive Phase One

Miramar, Florida, 33025, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

New Orleans Center For Clinical Research

Knoxville, Tennessee, 37920, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Liver Diseases

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 26, 2006

First Posted

September 29, 2006

Study Start

October 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

April 14, 2011

Record last verified: 2011-04

Locations

US(4)