A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function
- Registration Number
- NCT01419041
- Lead Sponsor
- Pfizer
- Brief Summary
The present study is being conducted to evaluate whether or not severe renal impairment has an effect on crizotinib Pharmacokinetics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A crizotinib CLCR: Creatinine clearance Arm B crizotinib CLCR: Creatinine clearance
- Primary Outcome Measures
Name Time Method Plasma AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for crizotinib 18 months Plasma Cmax (Maximum plasma concentration) for crizotinib 18 months
- Secondary Outcome Measures
Name Time Method AUCinf,u (unbound AUCinf) for PF-06260182 18 months AUClast,u (unbound AUClast) for PF-06260182 18 months Cmax,u (unbound Cmax) for PF-06260182 18 months Plasma AUClast (Area under the plasma concentration versus time curve from zero to the last quantifiable concentration) for crizotinib 18 months Tmax (Time to Cmax) for crizotinib 18 months t1/2 (terminal half-life) for crizotinib 18 months CL/F (Apparent oral clearance) for crizotinib 18 months Vz/F (Apparent volume of distribution after oral dose) for crizotinib 18 months fu (fraction of unbound drug in plasma) for crizotinib 18 months AUCinf,u (unbound AUCinf) for crizotinib 18 months AUClast,u (unbound AUClast) for crizotinib 18 months Cmax,u (unbound Cmax) for crizotinib 18 months CL/Fu (unbound apparent oral clearance) for crizotinib 18 months CLR (Renal clearance) for crizotinib 18 months Ae (Cumulative amount of drug recovered unchanged in the urine) for crizotinib 18 months Ae% (Cumulative amount of drug recovered unchanged in the urine expressed as fraction of administered dose) for crizotinib 18 months AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for PF-06260182 18 months AUClast (Area under the plasma concentration versus time curve from zero to the last quantifiable concentration) for PF-06260182 18 months Cmax (Maximum plasma concentration) for PF-06260182 18 months Tmax (Time to Cmax) for PF-06260182 18 months t1/2 (terminal half-life) for PF-06260182 18 months fu (fraction of unbound drug in plasma) for PF-06260182 18 months
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Saint Paul, Minnesota, United States