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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Crizotinib

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.

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.