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

Renal Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419041
• Other study ID #: A8081020
• Status: Completed
• Phase: Phase 1
• First received: August 16, 2011
• Last updated: September 28, 2012
• Start date: November 2011
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	DeLand	Florida
United States	Pfizer Investigational Site	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for crizotinib		18 months	No
Primary	Plasma Cmax (Maximum plasma concentration) for crizotinib		18 months	No
Secondary	Plasma AUClast (Area under the plasma concentration versus time curve from zero to the last quantifiable concentration) for crizotinib		18 months	No
Secondary	Tmax (Time to Cmax) for crizotinib		18 months	No
Secondary	t1/2 (terminal half-life) for crizotinib		18 months	No
Secondary	CL/F (Apparent oral clearance) for crizotinib		18 months	No
Secondary	Vz/F (Apparent volume of distribution after oral dose) for crizotinib		18 months	No
Secondary	fu (fraction of unbound drug in plasma) for crizotinib		18 months	No
Secondary	AUCinf,u (unbound AUCinf) for crizotinib		18 months	No
Secondary	AUClast,u (unbound AUClast) for crizotinib		18 months	No
Secondary	Cmax,u (unbound Cmax) for crizotinib		18 months	No
Secondary	CL/Fu (unbound apparent oral clearance) for crizotinib		18 months	No
Secondary	CLR (Renal clearance) for crizotinib		18 months	No
Secondary	Ae (Cumulative amount of drug recovered unchanged in the urine) for crizotinib		18 months	No
Secondary	Ae% (Cumulative amount of drug recovered unchanged in the urine expressed as fraction of administered dose) for crizotinib		18 months	No
Secondary	AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for PF-06260182		18 months	No
Secondary	AUClast (Area under the plasma concentration versus time curve from zero to the last quantifiable concentration) for PF-06260182		18 months	No
Secondary	Cmax (Maximum plasma concentration) for PF-06260182		18 months	No
Secondary	Tmax (Time to Cmax) for PF-06260182		18 months	No
Secondary	t1/2 (terminal half-life) for PF-06260182		18 months	No
Secondary	fu (fraction of unbound drug in plasma) for PF-06260182		18 months	No
Secondary	AUCinf,u (unbound AUCinf) for PF-06260182		18 months	No
Secondary	AUClast,u (unbound AUClast) for PF-06260182		18 months	No
Secondary	Cmax,u (unbound Cmax) for PF-06260182		18 months	No

External Links

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