NCT01233882

Bosutinib In Subjects With Renal Impairment

An Open-Label, Single-Dose, Parallel-Group Study Of The Pharmacokinetics And Safety Of Bosutinib In Subjects With Renal Impairment And Matched Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Disease, End-Stage
• Renal Insufficiency, Chronic
• Renal Insufficiency, Acute

Interventions

Type	Name	Description
DRUG	Bosutinib	Single dose of 200 mg of bosutinib in subjects with normal renal function
DRUG	Bosutinib	Single dose of 200 mg of bosutinib in subjects with mild renal impairment
DRUG	Bosutinib	Single dose of 200 mg of bosutinib in subjects with moderate renal impairment
DRUG	Bosutinib	Single dose of 200 mg of bosutinib in subjects with severe renal impairment

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-11-03
• Last updated: 2012-07-03

Locations

5 sites across 1 country: United States