Bosutinib In Subjects With Renal Impairment

Pfizer

Status and phase: Completed; Phase 1

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

Treatments: Drug: Bosutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01233882

B1871020

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 4 patient groups

Healthy Volunteers

Experimental group

Treatment:

Drug: Bosutinib

Drug: Bosutinib

Drug: Bosutinib

Drug: Bosutinib

Mild Renal Impairment

Experimental group

Treatment:

Drug: Bosutinib

Drug: Bosutinib

Drug: Bosutinib

Drug: Bosutinib

Moderate Renal Impairment

Experimental group

Treatment:

Drug: Bosutinib

Drug: Bosutinib

Drug: Bosutinib

Drug: Bosutinib

Severe Renal Impairment

Experimental group

Treatment:

Drug: Bosutinib

Drug: Bosutinib

Drug: Bosutinib

Drug: Bosutinib