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

NCT01419041 | Completed Phase 1

• 1 other identifier: A8081020
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Renal Impairment

Keywords

renal impairment; crizotinib; pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (22)

• 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

Study Arms (2)

Arm A

OTHER

CLCR: Creatinine clearance

Drug: crizotinib

Arm B

OTHER

CLCR: Creatinine clearance

Drug: crizotinib

Interventions

crizotinib DRUG

Single-dose oral 250 mg crizotinib in subjects with normal renal function (CLcr =\>90 mL/min)

Arm A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• All Subjects
• Renal allograft recipients.
• Any condition possibly affecting drug absorption.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Pfizer Investigational Site

Anaheim, California, 92801, United States

Location

Pfizer Investigational Site

DeLand, Florida, 32720, United States

Location

Pfizer Investigational Site

Saint Paul, Minnesota, 55114, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Crizotinib

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 17, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 1, 2012

Record last verified: 2012-09

Locations

US (3)