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ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
End-Stage Renal Disease, Chronic Renal Insufficiency, Acute Renal Insufficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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).
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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).
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End-Stage Renal Disease, Chronic Renal Insufficiency, Acute Renal InsufficiencyBosutinib In Subjects With Renal Impairment
NCT01233882
- DeLand, Florida
- Gainesville, Florida
- Miami, Florida
- Orlando, Florida
- Saint Paul, Minnesota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Bosutinib In Subjects With Renal Impairment | |||
| Official Title ICMJE | An Open-Label, Single-Dose, Parallel-Group Study Of The Pharmacokinetics And Safety Of Bosutinib In Subjects With Renal Impairment And Matched Healthy Adults | |||
| Brief 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. 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 34 | |||
| Original Estimated Enrollment ICMJE | 32 | |||
| Actual Study Completion Date ICMJE | June 2012 | |||
| Actual Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01233882 | |||
| Other Study ID Numbers ICMJE | B1871020 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | June 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||