Renal Disease, End-StagePhase 1NCT01233882
Bosutinib In Subjects With Renal Impairment
A Phase 1 study testing Bosutinib in people with Renal Disease, End-Stage and Renal Insufficiency, Chronic, run by Pfizer at 5 sites in United States.
Trial summary
This is a two-staged study of a single dose of 200 mg of bosutinib given to subjects with renal impairment and matching healthy volunteers. In Stage 1, only subjects with severe renal impairment and subjects with normal renal function will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Disease, End-Stage, Renal Insufficiency, Chronic, Renal Insufficiency, Acute
- What is being tested?
- Bosutinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2010to Jun 2012
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females, aged 18 to 65.
- Adequate hepatic function.
- Documented creatinine clearance by Cockroft-Gault formula indicative of the respective level of renal impairment: Severe renal impairment (CrCl <30 mL/min/1.73m2), moderate renal impairment (30 ≤ CrCl ≤50 mL/min/1.73m2), mild renal impairment (50 < CrCl≤80 mL/min/1.73m2) and normal renal function (CrCl >80 mL/min/1.73m2).
Who cannot join
- Use of any investigational drug or biologic within 4 weeks prior to the screening visit of during the screening period.
- Ongoing treatment with Digoxin or strong CYP3A4 inhibitors or inducers.
- Uncontrolled hypertension (for renally impaired subjects only).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Gainesville, Florida, 32608
Pfizer Investigational Site
Miami, Florida, 33169
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Saint Paul, Minnesota, 55114
About this study
Official title: An Open-Label, Single-Dose, Parallel-Group Study Of The Pharmacokinetics And Safety Of Bosutinib In Subjects With Renal Impairment And Matched Healthy Adults
This is a two-staged study of a single dose of 200 mg of bosutinib given to subjects with renal impairment and matching healthy volunteers. In Stage 1, only subjects with severe renal impairment and subjects with normal renal function will be enrolled. Subjects with mild and moderate renal impairment will be enrolled in Stage 2 if the results from Stage 1 suggest a substantial difference in PK profiles between subjects with severe renal impairment and subjects with normal renal function.
- Being tested
- Bosutinib
- Keywords
- Renal impairment, healthy volunteers
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosutinibDrug
Single dose of 200 mg of bosutinib in subjects with normal renal function
BosutinibDrug
Single dose of 200 mg of bosutinib in subjects with mild renal impairment
BosutinibDrug
Single dose of 200 mg of bosutinib in subjects with moderate renal impairment
BosutinibDrug
Single dose of 200 mg of bosutinib in subjects with severe renal impairment
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Not described Receives: Drug: Bosutinib |
| Mild Renal Impairment | Experimental | Not described Receives: Drug: Bosutinib |
| Moderate Renal Impairment | Experimental | Not described Receives: Drug: Bosutinib |
| Severe Renal Impairment | Experimental | Not described Receives: Drug: Bosutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentrations of bosutinib and its active metabolites will be measured, PK parameters (AUCinf, Cmax, AUClast, Tmax, t1/2, Cl/F and Vz/F) of bosutinib and its active metabolites will be calculated.
Measured: 11 days
Secondary outcomes (1)
Safety endpoints to include adverse events, physical examination findings, changes in clinical laboratory test results including ECGs, and changes in vital signs
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Disease, End-StageStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233882
- Sponsor's protocol ID
- B1871020
- Status last verified
- Jun 2012
- First submitted
- 28 Oct 2010
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Parallel-Group Study Of The Pharmacokinetics And Safety Of Bosutinib In Subjects With Renal Impairment And Matched Healthy Adults
- ClinicalTrials.gov ID
- NCT01233882
- Acronym / sponsor ID
- B1871020
- Keywords
- Renal impairment, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 Nov 2010 (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.
This is a two-staged study of a single dose of 200 mg of bosutinib given to subjects with renal impairment and matching healthy volunteers. In Stage 1, only subjects with severe renal impairment and subjects with normal renal function will be enrolled. Subjects with mild and moderate renal impairment will be enrolled in Stage 2 if the results from Stage 1 suggest a substantial difference in PK profiles between subjects with severe renal impairment and subjects with normal renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Drug: Bosutinib |
| Mild Renal Impairment | Experimental | Drug: Bosutinib |
| Moderate Renal Impairment | Experimental | Drug: Bosutinib |
| Severe Renal Impairment | Experimental | Drug: Bosutinib |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females, aged 18 to 65.
- Adequate hepatic function.
- Documented creatinine clearance by Cockroft-Gault formula indicative of the respective level of renal impairment: Severe renal impairment (CrCl <30 mL/min/1.73m2), moderate renal impairment (30 ≤ CrCl ≤50 mL/min/1.73m2), mild renal impairment (50 < CrCl≤80 mL/min/1.73m2) and normal renal function (CrCl >80 mL/min/1.73m2).
Key exclusion criteria (3 listed)
- Use of any investigational drug or biologic within 4 weeks prior to the screening visit of during the screening period.
- Ongoing treatment with Digoxin or strong CYP3A4 inhibitors or inducers.
- Uncontrolled hypertension (for renally impaired subjects only).
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 |
|---|---|---|
| BosutinibSingle dose of 200 mg of bosutinib in subjects with normal renal function | Drug | Healthy Volunteers |
| BosutinibSingle dose of 200 mg of bosutinib in subjects with mild renal impairment | Drug | Mild Renal Impairment |
| BosutinibSingle dose of 200 mg of bosutinib in subjects with moderate renal impairment | Drug | Moderate Renal Impairment |
| BosutinibSingle dose of 200 mg of bosutinib in subjects with severe renal impairment | Drug | Severe Renal Impairment |
Primary outcome
Serum concentrations of bosutinib and its active metabolites will be measured, PK parameters (AUCinf, Cmax, AUClast, Tmax, t1/2, Cl/F and Vz/F) of bosutinib and its active metabolites will be calculated.
Time frame: 11 days
1 secondary outcome
Safety endpoints to include adverse events, physical examination findings, changes in clinical laboratory test results including ECGs, and changes in vital signs
Time frame: 11 days
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 3 Jul 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bosutinib in people with Renal Disease, End-Stage and Renal Insufficiency, Chronic, run by Pfizer at 5 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 3 inclusion and 3 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 3 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Serum concentrations of bosutinib and its active metabolites will be measured, PK parameters (AUCinf, Cmax, AUClast, Tmax, t1/2, Cl/F and Vz/F) of bosutinib and its active metabolites will be calculated. (time frame: 11 days). It is what the study was designed to measure, not a finding.
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 3 Jul 2012.