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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Pfizer Investigational Site
DeLand, Florida, United States
Pfizer Investigational Site
Gainesville, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Orlando, Florida, United States
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
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
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Single dose of 200 mg of bosutinib in subjects with severe renal impairment
Pfizer Investigational Site
Saint Paul, Minnesota, United States