Trial record 14 of 2190 for:
"Kidney Failure"
Bosutinib In Subjects With Renal Impairment
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01233882
First received: October 28, 2010
Last updated: June 29, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Disease, End-Stage Renal Insufficiency, Chronic Renal Insufficiency, Acute |
Drug: Bosutinib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Chronic Kidney Disease
Drug Information available for:
Bosutinib
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 34 |
| Study Start Date: | December 2010 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Healthy Volunteers |
Drug: Bosutinib
Single dose of 200 mg of bosutinib in subjects with normal renal function
|
| Experimental: Mild Renal Impairment |
Drug: Bosutinib
Single dose of 200 mg of bosutinib in subjects with mild renal impairment
|
| Experimental: Moderate Renal Impairment |
Drug: Bosutinib
Single dose of 200 mg of bosutinib in subjects with moderate renal impairment
|
| Experimental: Severe Renal Impairment |
Drug: Bosutinib
Single dose of 200 mg of bosutinib in subjects with severe renal impairment
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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:
- 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233882
Locations
| United States, Florida | |
| Pfizer Investigational Site | |
| DeLand, Florida, United States, 32720 | |
| Pfizer Investigational Site | |
| Gainesville, Florida, United States, 32608 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33169 | |
| Pfizer Investigational Site | |
| Orlando, Florida, United States, 32806 | |
| United States, Minnesota | |
| Pfizer Investigational Site | |
| Saint Paul, Minnesota, United States, 55114 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01233882 History of Changes |
| Other Study ID Numbers: | B1871020 |
| Study First Received: | October 28, 2010 |
| Last Updated: | June 29, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Renal impairment healthy volunteers |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Renal Insufficiency |
Renal Insufficiency, Chronic Acute Kidney Injury Urologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013