Liver DiseasesNCT00382668
A Study of Dasatinib to See How Liver Impaired and Healthy Subjects Process and React to the Study Drug
An observational study of Liver Diseases, run by Bristol-Myers Squibb at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Dasatinib
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2006to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
New Orleans Center For Clinical Research
Knoxville, Tennessee, 37920
University Of Miami
Miami, Florida, 33136
Comprehensive Phase One
Miramar, Florida, 33025
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: Single-Dose Pharmacokinetics of Dasatinib in Subjects With Hepatic Impairment Compared to Healthy Adult Subjects
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.
- Conditions
- Liver Diseases
- Being tested
- Dasatinib
- Keywords
- hepatically impaired
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called Sprycel
Tablets, Oral, 50 mg, once daily, for one day
DasatinibDrug
Also called Sprycel
Tablets, Oral, 20 mg, once daily for one day
DasatinibDrug
Also called Sprycel
Tablets, Oral, 70 mg, once daily for one day
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: Dasatinib | |
| B | Not described Receives: Drug: Dasatinib | |
| C | Not described Receives: Drug: Dasatinib |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382668
- Sponsor's protocol ID
- CA180-051
- Status last verified
- Apr 2011
- First submitted
- 26 Sep 2006
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Pharmacokinetics of Dasatinib in Subjects With Hepatic Impairment Compared to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00382668
- Acronym / sponsor ID
- CA180-051
- Conditions
- Liver Diseases
- Keywords
- hepatically impaired
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 29 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: Dasatinib |
| B | – | Drug: Dasatinib |
| C | – | Drug: Dasatinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasatinibAlso: SprycelTablets, Oral, 50 mg, once daily, for one day | Drug | A |
| DasatinibAlso: SprycelTablets, Oral, 20 mg, once daily for one day | Drug | B |
| DasatinibAlso: SprycelTablets, Oral, 70 mg, once daily for one day | Drug | C |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by Bristol-Myers Squibb at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2011.