A Phase I, Single Dose, Parallel-Group Study To Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function

Pfizer1 site in 1 country16 target enrollmentNovember 2011

ConditionsRenal Impairment

Interventionscrizotinib

Drugscrizotinib

Overview

Phase: Phase 1
Intervention: crizotinib
Conditions: Renal Impairment
Sponsor: Pfizer
Enrollment: 16
Locations: 1
Primary Endpoint: Plasma AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for crizotinib
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The present study is being conducted to evaluate whether or not severe renal impairment has an effect on crizotinib Pharmacokinetics.

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

August 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All Subjects
•Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 65 years, inclusive ('healthy' is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG, and clinical laboratory tests).
•Body Mass Index (BMI) of 18 to 40 kg/m2 inclusive; and a total body weight \>50 kg (\>110 lbs).
•Subjects with Normal Renal Function (Group 1)
•Normal renal function (CLcr =\>90 mL/min) during the screening period.
•Matched 1-to-1 to subjects in Group 2 with respect to age (+/-5 years), weight (+/-10 kg), gender, and race according to protocol.
•Subjects with Severe Renal Impairment (Groups 2)
•Good general health commensurate with the population with chronic kidney disease.
•Severe renal impairment (CLcr\<30 mL/min) during the screening period.

Exclusion Criteria

•All Subjects
•Renal allograft recipients.
•Any condition possibly affecting drug absorption.
•12 lead ECG demonstrating QTc \>470 msec at screening.
•Urinary incontinence without catheterization.
•A positive urine drug screen.
•History of regular alcohol consumption.
•Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives preceding the first dose of study medication.
•Pregnant or nursing females; females of childbearing potential, including those with tubal ligation.
•Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.

Arms & Interventions

Arm A

CLCR: Creatinine clearance

Intervention: crizotinib

Arm B

CLCR: Creatinine clearance

Intervention: crizotinib

Outcomes

Primary Outcomes

Plasma AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for crizotinib

Time Frame: 18 months

Plasma Cmax (Maximum plasma concentration) for crizotinib

Time Frame: 18 months

Secondary Outcomes

Cmax,u (unbound Cmax) for PF-06260182(18 months)
AUClast,u (unbound AUClast) for PF-06260182(18 months)
Plasma AUClast (Area under the plasma concentration versus time curve from zero to the last quantifiable concentration) for crizotinib(18 months)
Tmax (Time to Cmax) for crizotinib(18 months)
t1/2 (terminal half-life) for crizotinib(18 months)
CL/F (Apparent oral clearance) for crizotinib(18 months)
Vz/F (Apparent volume of distribution after oral dose) for crizotinib(18 months)
fu (fraction of unbound drug in plasma) for crizotinib(18 months)
AUCinf,u (unbound AUCinf) for crizotinib(18 months)
AUClast,u (unbound AUClast) for crizotinib(18 months)
Cmax,u (unbound Cmax) for crizotinib(18 months)
CL/Fu (unbound apparent oral clearance) for crizotinib(18 months)
CLR (Renal clearance) for crizotinib(18 months)
Ae (Cumulative amount of drug recovered unchanged in the urine) for crizotinib(18 months)
Ae% (Cumulative amount of drug recovered unchanged in the urine expressed as fraction of administered dose) for crizotinib(18 months)
AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for PF-06260182(18 months)
AUClast (Area under the plasma concentration versus time curve from zero to the last quantifiable concentration) for PF-06260182(18 months)
Cmax (Maximum plasma concentration) for PF-06260182(18 months)
Tmax (Time to Cmax) for PF-06260182(18 months)
t1/2 (terminal half-life) for PF-06260182(18 months)
fu (fraction of unbound drug in plasma) for PF-06260182(18 months)
AUCinf,u (unbound AUCinf) for PF-06260182(18 months)