A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:November 2011
End Date:September 2012
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

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


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


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.

Subjects with Severe Renal Impairment (Groups 2)

- Subjects with any significant hepatic, cardiac or pulmonary disease (apart from
stable ischemic heart disease), or subjects who are clinically nephrotic.

- Subjects requiring hemodialysis.

- Subjects with strict fluid restriction (ie, <1500 mL/24 hours).

- Significant bleeding diathesis which could preclude multiple venipuncture.

- Use of food or drugs that are CYP3A4 inhibitors and inducers.

- Herbal supplements and hormone replacement therapy must be discontinued 28 days prior
to the first dose of trial medication

- Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
We found this trial at
3
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Duluth, Minnesota 55805
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Atlantis, Florida 33462
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Los Angeles, California 90027
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Los Angeles, CA
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