Bosutinib In Subjects With Renal Impairment
| Status: | Archived |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | December 2010 |
| End Date: | July 2011 |
An Open-Label, Single-Dose, Parallel-Group Study Of The Pharmacokinetics And Safety Of Bosutinib In Subjects With Renal Impairment And Matched Healthy Adults
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.
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