drugset / Trial / NCT01233882

Bosutinib In Subjects With Renal Impairment

NCT01233882

Phase 1 Completed 34 enrolled Pfizer
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2010-12
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Bosutinib Small molecule 200 mg