The aim of the study is to assess whether renal impairment could affect fevipiprant pharmacokinetics (PK) to the extent that dosage adjustment is appropriate for this patient population. The study also aims to determine the effect of dialysis on the fevipiprant pharmacokinetic profile as the procedure might remove a significant fraction of the drug.
The purpose of this study is to determine if the pharmacokinetic profile of fevipiprant is different in patients with renal impariment compared to healthy matched volunteers to an extent that would require an adjustment of the dosage. Data from this study will be used to guide enrollment criteria in future clinical trials and to support regulatory submission and labeling information
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Grünstadt, Germany
Pharmacokinetics: Plasma concentration of fevipiprant by AUClast
AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
Time frame: 68 hours post dose
Pharmacokinetics: Plasma concentration of fevipiprant by AUCinf
AUCinf is the area under the plasma concentration-time curve from time zero to infinity
Time frame: 68 hours post dose
Pharmacokinetics: Plasma concentration of fevipiprant by Cmax
Cmax is the observed maximum plasma concentration following drug administration
Time frame: 68 hours post dose
Pharmacokinetics: Plasma contentration of fevipiprant by AUC0-68h
AUC0-68h is the area under the plasma concentration from time zero to time 68 hours of the last measured concentration above the limit of quantification after dosing
Time frame: 68 hours post dose
Relationship between plasma pharmacokinetics of fevipiprant by AUClast and between eGFR as well as creatinine clearance
AUClast (the area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration ) related to eGFR estimated by the Modification of Diet in Renal Disease (MDRD) formula, and Cockcroft-Gault (C-G) estimated creatinine clearance
Time frame: 68 hours post dose
Relationship between plasma pharmacokinetics of fevipiprant by AUCinf and between eGFR as well as creatinine clearance
AUCinf (the area under the plasma concentration time curve from time zero to infinity) related to eGFR estimated by the Modification of Diet in Renal Disease (MDRD) formula, and Cockcroft-Gault (C-G) estimated creatinine clearance
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450 mg
Time frame: 68 hours post dose
Relationship between plasma pharmacokinetics of fevipiprant by Cmax and between eGFR as well as creatinine clearance
Cmax (observed maximum plasma concentration following drug administration) related to eGFR estimated by the Modification of Diet in Renal Disease (MDRD) formula, and Cockcroft-Gault (C-G) estimated creatinine clearance
Time frame: 68 hours post dose
Pharmacokinetics of the metabolite CCN362 by AUClast
AUClast is the area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration
Time frame: 68 hours post dose
Pharmacokinetics of the metabolite CCN362 by AUCinf
AUCinf is the area under the plasma concentration time curve from time zero to infinity
Time frame: 68 hours post dose
Pharmacokinetics of the metabolite CCN362 by Cmax
Cmax is the observed maximum plasma concentration following drug administration
Time frame: 68 hours post dose
Pharmacokinetics: plasma concentration of fevipiprant in patients with End Stage Renal Disease (ESRD)
Partial AUCs (AUCt1-t2) covering the time interval of dialysis, Cmax and total AUCs (AUC0-68h and/or AUCinf) will be compared
Time frame: 68 hours post dose
urinary excretion of fevipiprant and metabolite in patients with renal impairment compared to healthy controls
Renal clearance (CLr) and fraction of dose excreted in urine for fevipiprant and metabolite
Time frame: 24 hours post dose