Bosutinib In Subjects With Renal Impairment

Phase 1

Completed

• Conditions: Renal Disease, End-Stage; Renal Insufficiency, Chronic; Renal Insufficiency, Acute
• Interventions: Drug: Bosutinib

• Registration Number: NCT01233882
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-03
• Study Start: 2010-12
• Status Verified: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild Renal Impairment	Bosutinib	-
Healthy Volunteers	Bosutinib	-
Moderate Renal Impairment	Bosutinib	-
Severe Renal Impairment	Bosutinib	-

Primary Outcome Measures

Name	Time	Method
Serum concentrations of bosutinib and its active metabolites will be measured, PK parameters (AUCinf, Cmax, AUClast, Tmax, t1/2, Cl/F and Vz/F) of bosutinib and its active metabolites will be calculated.	11 days

Secondary Outcome Measures

Name	Time	Method
Safety endpoints to include adverse events, physical examination findings, changes in clinical laboratory test results including ECGs, and changes in vital signs	11 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Saint Paul, Minnesota, United States