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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01419041
Other study ID # A8081020
Secondary ID
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


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
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