Bosutinib In Subjects With Renal Impairment

Completed · Phase 1

Conditions studied: Renal Disease, End-Stage, Renal Insufficiency, Chronic, Renal Insufficiency, Acute

In brief

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.

Key facts

Study ID

NCT01233882

Run by

Pfizer

People needed

34

Starts

2010-12-01

Expected to finish

2012-06-01

Last updated by the study team

2012-07-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and females, aged 18 to 65.
• Adequate hepatic function.
• Documented creatinine clearance by Cockroft-Gault formula indicative of the respective level of renal impairment: Severe renal impairment (CrCl <30 mL/min/1.73m2), moderate renal impairment (30 ≤ CrCl ≤50 mL/min/1.73m2), mild renal impairment (50 < CrCl≤80 mL/min/1.73m2) and normal renal function (CrCl >80 mL/min/1.73m2).

You may not qualify if…

• Use of any investigational drug or biologic within 4 weeks prior to the screening visit of during the screening period.
• Ongoing treatment with Digoxin or strong CYP3A4 inhibitors or inducers.
• Uncontrolled hypertension (for renally impaired subjects only).

Where it is running

• 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
• Pfizer Investigational Site — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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