An Open-Label, Single-Dose, Parallel-Group Study Of The Pharmacokinetics And Safety Of Bosutinib In Subjects With Renal Impairment And Matched Healthy Adults
Sponsor study identifier
interventional
34
1 country
5
Study Start
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2012
Actual (reported)Study Completion
June 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 28, 2010
Actual (reported)November 3, 2010
Actual (reported)December 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 2012
Actual (reported)June 2012
Actual (reported)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
Safety endpoints to include adverse events, physical examination findings, changes in clinical laboratory test results including ECGs, and changes in vital signs
11 days
Single dose of 200 mg of bosutinib in subjects with normal renal function
Single dose of 200 mg of bosutinib in subjects with mild renal impairment
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
Pfizer CT.gov Call Center
Pfizer
34 participants (actual enrollment reported by the registry).
First Submitted
October 28, 2010
First Posted
November 3, 2010
Study Start
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
Single dose of 200 mg of bosutinib in subjects with moderate renal impairment
Single dose of 200 mg of bosutinib in subjects with severe renal impairment
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 2012
Actual (reported)Study Completion
June 2012
Actual (reported)Last Updated
July 3, 2012
Record last verified: 2012-06
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Source: ClinicalTrials.gov.
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