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

Primary Purpose

Renal Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

crizotinib

About this trial

This is an interventional basic science trial for Renal Impairment focused on measuring renal impairment, crizotinib, pharmacokinetics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Arm A

Arm B

Arm Description

CLCR: Creatinine clearance

Outcomes

Primary Outcome Measures

Plasma AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for crizotinib

Plasma Cmax (Maximum plasma concentration) for crizotinib

Secondary Outcome Measures

Plasma AUClast (Area under the plasma concentration versus time curve from zero to the last quantifiable concentration) for crizotinib

Tmax (Time to Cmax) for crizotinib

t1/2 (terminal half-life) for crizotinib

CL/F (Apparent oral clearance) for crizotinib

Vz/F (Apparent volume of distribution after oral dose) for crizotinib

fu (fraction of unbound drug in plasma) for crizotinib

AUCinf,u (unbound AUCinf) for crizotinib

AUClast,u (unbound AUClast) for crizotinib

Cmax,u (unbound Cmax) for crizotinib

CL/Fu (unbound apparent oral clearance) for crizotinib

CLR (Renal clearance) for crizotinib

Ae (Cumulative amount of drug recovered unchanged in the urine) for crizotinib

Ae% (Cumulative amount of drug recovered unchanged in the urine expressed as fraction of administered dose) for crizotinib

AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for PF-06260182

AUClast (Area under the plasma concentration versus time curve from zero to the last quantifiable concentration) for PF-06260182

Cmax (Maximum plasma concentration) for PF-06260182

Tmax (Time to Cmax) for PF-06260182

t1/2 (terminal half-life) for PF-06260182

fu (fraction of unbound drug in plasma) for PF-06260182

AUCinf,u (unbound AUCinf) for PF-06260182

AUClast,u (unbound AUClast) for PF-06260182

Cmax,u (unbound Cmax) for PF-06260182

Full Information

NCT ID

NCT01419041

First Posted

August 16, 2011

Last Updated

September 28, 2012

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01419041

Brief Title

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

Official Title

A Phase I, Single Dose, Parallel-Group Study To Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment

Keywords

renal impairment, crizotinib, pharmacokinetics

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Other

Arm Description

CLCR: Creatinine clearance

Arm Title

Arm B

Arm Type

Other

Arm Description

CLCR: Creatinine clearance

Intervention Type

Drug

Intervention Name(s)

crizotinib

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

crizotinib

Intervention Description

Single-dose oral 250 mg crizotinib in subjects with severe renal impairment (CLcr <30 mL/min)

Primary Outcome Measure Information:

Title

Plasma AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for crizotinib

Time Frame

18 months

Title

Plasma Cmax (Maximum plasma concentration) for crizotinib

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Plasma AUClast (Area under the plasma concentration versus time curve from zero to the last quantifiable concentration) for crizotinib

Time Frame

18 months

Title

Tmax (Time to Cmax) for crizotinib

Time Frame

18 months

Title

t1/2 (terminal half-life) for crizotinib

Time Frame

18 months

Title

CL/F (Apparent oral clearance) for crizotinib

Time Frame

18 months

Title

Vz/F (Apparent volume of distribution after oral dose) for crizotinib

Time Frame

18 months

Title

fu (fraction of unbound drug in plasma) for crizotinib

Time Frame

18 months

Title

AUCinf,u (unbound AUCinf) for crizotinib

Time Frame

18 months

Title

AUClast,u (unbound AUClast) for crizotinib

Time Frame

18 months

Title

Cmax,u (unbound Cmax) for crizotinib

Time Frame

18 months

Title

CL/Fu (unbound apparent oral clearance) for crizotinib

Time Frame

18 months

Title

CLR (Renal clearance) for crizotinib

Time Frame

18 months

Title

Ae (Cumulative amount of drug recovered unchanged in the urine) for crizotinib

Time Frame

18 months

Title

Ae% (Cumulative amount of drug recovered unchanged in the urine expressed as fraction of administered dose) for crizotinib

Time Frame

18 months

Title

AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for PF-06260182

Time Frame

18 months

Title

AUClast (Area under the plasma concentration versus time curve from zero to the last quantifiable concentration) for PF-06260182

Time Frame

18 months

Title

Cmax (Maximum plasma concentration) for PF-06260182

Time Frame

18 months

Title

Tmax (Time to Cmax) for PF-06260182

Time Frame

18 months

Title

t1/2 (terminal half-life) for PF-06260182

Time Frame

18 months

Title

fu (fraction of unbound drug in plasma) for PF-06260182

Time Frame

18 months

Title

AUCinf,u (unbound AUCinf) for PF-06260182

Time Frame

18 months

Title

AUClast,u (unbound AUClast) for PF-06260182

Time Frame

18 months

Title

Cmax,u (unbound Cmax) for PF-06260182

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Pfizer Investigational Site

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

Pfizer Investigational Site

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55114

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8081020&StudyName=A%20Study%20to%20Evaluate%20The%20Pharmacokinetics%20Of%20Crizotinib%20%28PF-02341066%29%20In%20Subjects%20With%20Impaired%20Renal%20Function%20

Description

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

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