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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Renal Impairment

Treatments

Drug: crizotinib

Study type

Interventional

Funder types

Industry

Identifiers

A8081020

Details and patient eligibility

About

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

Enrollment

16 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.