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The present study is being conducted to evaluate whether or not severe renal impairment has an effect on crizotinib Pharmacokinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Other | CLCR: Creatinine clearance |
|
| Arm B | Other | CLCR: Creatinine clearance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| crizotinib | Drug | Single-dose oral 250 mg crizotinib in subjects with normal renal function (CLcr =>90 mL/min) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
All Subjects
Subjects with Normal Renal Function (Group 1)
Subjects with Severe Renal Impairment (Groups 2)
Exclusion Criteria:
All Subjects
Subjects with Severe Renal Impairment (Groups 2)
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Anaheim | California | 92801 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077547 | Crizotinib |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
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| crizotinib | Drug | Single-dose oral 250 mg crizotinib in subjects with severe renal impairment (CLcr <30 mL/min) |
|
| 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 |
| 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 |
| DeLand |
| Florida |
| 32720 |
| United States |
| Pfizer Investigational Site | Saint Paul | Minnesota | 55114 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011725 |
| Pyridines |