Status:
COMPLETED
A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function
Lead Sponsor:
Pfizer
Conditions:
Renal Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The present study is being conducted to evaluate whether or not severe renal impairment has an effect on crizotinib Pharmacokinetics.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01419041
Start Date
November 1 2011
End Date
August 1 2012
Last Update
October 1 2012
Active Locations (3)
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1
Pfizer Investigational Site
Anaheim, California, United States, 92801
2
Pfizer Investigational Site
DeLand, Florida, United States, 32720
3
Pfizer Investigational Site
Saint Paul, Minnesota, United States, 55114