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Bosutinib In Subjects With Renal Impairment

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bosutinib
Bosutinib
Bosutinib
Bosutinib
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Disease, End-Stage focused on measuring Renal impairment, healthy volunteers

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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).

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Healthy Volunteers

Mild Renal Impairment

Moderate Renal Impairment

Severe Renal Impairment

Arm Description

Outcomes

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.

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

Full Information

First Posted
October 28, 2010
Last Updated
June 29, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01233882
Brief Title
Bosutinib In Subjects With Renal Impairment
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 Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Disease, End-Stage, Renal Insufficiency, Chronic, Renal Insufficiency, Acute
Keywords
Renal impairment, healthy volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Title
Mild Renal Impairment
Arm Type
Experimental
Arm Title
Moderate Renal Impairment
Arm Type
Experimental
Arm Title
Severe Renal Impairment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bosutinib
Intervention Description
Single dose of 200 mg of bosutinib in subjects with normal renal function
Intervention Type
Drug
Intervention Name(s)
Bosutinib
Intervention Description
Single dose of 200 mg of bosutinib in subjects with mild renal impairment
Intervention Type
Drug
Intervention Name(s)
Bosutinib
Intervention Description
Single dose of 200 mg of bosutinib in subjects with moderate renal impairment
Intervention Type
Drug
Intervention Name(s)
Bosutinib
Intervention Description
Single dose of 200 mg of bosutinib in subjects with severe renal impairment
Primary Outcome Measure Information:
Title
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.
Time Frame
11 days
Secondary Outcome Measure Information:
Title
Safety endpoints to include adverse events, physical examination findings, changes in clinical laboratory test results including ECGs, and changes in vital signs
Time Frame
11 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Pfizer Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Pfizer Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1871020&StudyName=Bosutinib%20In%20Subjects%20With%20Renal%20Impairment
Description
To obtain contact information for a study center near you, click here.

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Bosutinib In Subjects With Renal Impairment

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