| Trial ID: | L1092 |
| Source ID: | NCT01233882
|
| Associated Drug: |
Bosutinib
|
| Title: |
Bosutinib In Subjects With Renal Impairment
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Disease, End-Stage|Renal Insufficiency, Chronic|Renal Insufficiency, Acute
|
| Interventions: |
DRUG: Bosutinib|DRUG: Bosutinib|DRUG: Bosutinib|DRUG: Bosutinib
|
| Outcome Measures: |
Primary: 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., 11 days | Secondary: Safety endpoints to include adverse events, physical examination findings, changes in clinical laboratory test results including ECGs, and changes in vital signs, 11 days
|
| Sponsor/Collaborators: |
Sponsor: Pfizer
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
34
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-12
|
| Completion Date: |
2012-06
|
| Results First Posted: |
|
| Last Update Posted: |
2012-07-03
|
| Locations: |
Pfizer Investigational Site, DeLand, Florida, 32720, United States|Pfizer Investigational Site, Gainesville, Florida, 32608, United States|Pfizer Investigational Site, Miami, Florida, 33169, United States|Pfizer Investigational Site, Orlando, Florida, 32806, United States|Pfizer Investigational Site, Saint Paul, Minnesota, 55114, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01233882
|
