A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function
NCT ID: NCT01419041
Last Updated: 2012-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2011-11-30
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Arm A
CLCR: Creatinine clearance
crizotinib
Single-dose oral 250 mg crizotinib in subjects with normal renal function (CLcr =\>90 mL/min)
Arm B
CLCR: Creatinine clearance
crizotinib
Single-dose oral 250 mg crizotinib in subjects with severe renal impairment (CLcr \<30 mL/min)
Interventions
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crizotinib
Single-dose oral 250 mg crizotinib in subjects with normal renal function (CLcr =\>90 mL/min)
crizotinib
Single-dose oral 250 mg crizotinib in subjects with severe renal impairment (CLcr \<30 mL/min)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
DeLand, Florida, United States
Pfizer Investigational Site
Saint Paul, Minnesota, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A8081020
Identifier Type: -
Identifier Source: org_study_id