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Bosutinib In Subjects With Renal Impairment

NCT ID: NCT01233882

Last Updated: 2012-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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

Keywords

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Renal impairment healthy volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

Group Type EXPERIMENTAL

Bosutinib

Intervention Type DRUG

Single dose of 200 mg of bosutinib in subjects with normal renal function

Mild Renal Impairment

Group Type EXPERIMENTAL

Bosutinib

Intervention Type DRUG

Single dose of 200 mg of bosutinib in subjects with mild renal impairment

Moderate Renal Impairment

Group Type EXPERIMENTAL

Bosutinib

Intervention Type DRUG

Single dose of 200 mg of bosutinib in subjects with moderate renal impairment

Severe Renal Impairment

Group Type EXPERIMENTAL

Bosutinib

Intervention Type DRUG

Single dose of 200 mg of bosutinib in subjects with severe renal impairment

Interventions

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Bosutinib

Single dose of 200 mg of bosutinib in subjects with normal renal function

Intervention Type DRUG

Bosutinib

Single dose of 200 mg of bosutinib in subjects with mild renal impairment

Intervention Type DRUG

Bosutinib

Single dose of 200 mg of bosutinib in subjects with moderate renal impairment

Intervention Type DRUG

Bosutinib

Single dose of 200 mg of bosutinib in subjects with severe renal impairment

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

DeLand, Florida, United States

Site Status

Pfizer Investigational Site

Gainesville, Florida, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Orlando, Florida, United States

Site Status

Pfizer Investigational Site

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1871020&StudyName=Bosutinib%20In%20Subjects%20With%20Renal%20Impairment

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1871020

Identifier Type: -

Identifier Source: org_study_id