Bosutinib In Subjects With Renal Impairment

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01233882

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

6.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Disease, End-Stage Renal Insufficiency, Chronic Renal Insufficiency, Acute	Drug: Bosutinib Drug: Bosutinib Drug: Bosutinib Drug: Bosutinib	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy Volunteers	Drug: Bosutinib Single dose of 200 mg of bosutinib in subjects with normal renal function
Experimental: Mild Renal Impairment	Drug: Bosutinib Single dose of 200 mg of bosutinib in subjects with mild renal impairment
Experimental: Moderate Renal Impairment	Drug: Bosutinib Single dose of 200 mg of bosutinib in subjects with moderate renal impairment
Experimental: Severe Renal Impairment	Drug: Bosutinib Single dose of 200 mg of bosutinib in subjects with severe renal impairment

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	DeLand	Florida	United States	32720
2	Pfizer Investigational Site	Gainesville	Florida	United States	32608
3	Pfizer Investigational Site	Miami	Florida	United States	33169
4	Pfizer Investigational Site	Orlando	Florida	United States	32806
5	Pfizer Investigational Site	Saint Paul	Minnesota	United States	55114