Pharmacokinetics and pharmacodynamics of erythropoietin receptor in healthy volunteers. 2008

Wojciech Krzyzanski, and Elzbieta Wyska
Department of Pharmaceutical Sciences, University at Buffalo, State University of New York, Buffalo, NY 14260, USA. wk@buffalo.edu

The purpose of this study was to apply the target-mediated drug disposition (TMDD) pharmacokinetic (PK) model to describe binding, internalization, and turnover of erythropoietin receptor (EPOR). This model allows one to determine from free drug (C) PK data not only parameters describing linear disposition of EPO such as the elimination rate constant (kel) and volume of distribution (Vc), but also the total receptor concentration (Rtot0), drug-receptor complex (RC) internalization rate constant (kint), as well as synthesis and degradation rate constants (ksyn and kdeg) for the receptor turnover. The previously published data on PK of recombinant EPO (rHuEPO) in humans and the results of EPOR binding studies were used for analysis. The estimated PK parameters were used to simulate time courses of free and bound EPOR after IV administration of clinically relevant rHuEPO doses. The estimates of kel=0.106 h(-1) and Vc=0.032 l/kg are consistent with reported in the literature values of rHuEPO linear disposition parameters. The determined value of Rtot0 was 66.35 pM and the half-life for EPOR degradation was 8.8 h. Computer simulations showed a very rapid binding phase in the EPOR time profile followed by a decline to a nadir, and a subsequent return to the baseline. The nadir values decreased with increasing doses and resulted in the maximum values of the bound fractions of the total EPOR in the ranges 33-99%. At the baseline conditions, only 3.1% of EPOR were occupied. The saturation of EPOR was correlated with the time C remained above the KD level. In conclusion, the time courses of serum rHuEPO concentrations contain information about internalization and turnover of EPOR. Kinetics of EPOR can be utilized to determine the relationship between the pharmacologic effect and exposure to rHuEPO.

UI MeSH Term Description Entries
D008297 Male Males
D008954 Models, Biological Theoretical representations that simulate the behavior or activity of biological processes or diseases. For disease models in living animals, DISEASE MODELS, ANIMAL is available. Biological models include the use of mathematical equations, computers, and other electronic equipment. Biological Model,Biological Models,Model, Biological,Models, Biologic,Biologic Model,Biologic Models,Model, Biologic
D011485 Protein Binding The process in which substances, either endogenous or exogenous, bind to proteins, peptides, enzymes, protein precursors, or allied compounds. Specific protein-binding measures are often used as assays in diagnostic assessments. Plasma Protein Binding Capacity,Binding, Protein
D011994 Recombinant Proteins Proteins prepared by recombinant DNA technology. Biosynthetic Protein,Biosynthetic Proteins,DNA Recombinant Proteins,Recombinant Protein,Proteins, Biosynthetic,Proteins, Recombinant DNA,DNA Proteins, Recombinant,Protein, Biosynthetic,Protein, Recombinant,Proteins, DNA Recombinant,Proteins, Recombinant,Recombinant DNA Proteins,Recombinant Proteins, DNA
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D003198 Computer Simulation Computer-based representation of physical systems and phenomena such as chemical processes. Computational Modeling,Computational Modelling,Computer Models,In silico Modeling,In silico Models,In silico Simulation,Models, Computer,Computerized Models,Computer Model,Computer Simulations,Computerized Model,In silico Model,Model, Computer,Model, Computerized,Model, In silico,Modeling, Computational,Modeling, In silico,Modelling, Computational,Simulation, Computer,Simulation, In silico,Simulations, Computer
D004921 Erythropoietin Glycoprotein hormone, secreted chiefly by the KIDNEY in the adult and the LIVER in the FETUS, that acts on erythroid stem cells of the BONE MARROW to stimulate proliferation and differentiation.
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D013997 Time Factors Elements of limited time intervals, contributing to particular results or situations. Time Series,Factor, Time,Time Factor
D014018 Tissue Distribution Accumulation of a drug or chemical substance in various organs (including those not relevant to its pharmacologic or therapeutic action). This distribution depends on the blood flow or perfusion rate of the organ, the ability of the drug to penetrate organ membranes, tissue specificity, protein binding. The distribution is usually expressed as tissue to plasma ratios. Distribution, Tissue,Distributions, Tissue,Tissue Distributions

Related Publications

Wojciech Krzyzanski, and Elzbieta Wyska
February 1983, International journal of clinical pharmacology, therapy, and toxicology,
Wojciech Krzyzanski, and Elzbieta Wyska
December 1999, Arzneimittel-Forschung,
Wojciech Krzyzanski, and Elzbieta Wyska
January 2000, European journal of clinical pharmacology,
Wojciech Krzyzanski, and Elzbieta Wyska
January 2008, Journal of clinical pharmacology,
Wojciech Krzyzanski, and Elzbieta Wyska
January 2015, Frontiers in pharmacology,
Wojciech Krzyzanski, and Elzbieta Wyska
July 2007, European journal of clinical pharmacology,
Wojciech Krzyzanski, and Elzbieta Wyska
November 2004, Journal of clinical pharmacology,
Wojciech Krzyzanski, and Elzbieta Wyska
January 2009, Journal of clinical pharmacology,
Wojciech Krzyzanski, and Elzbieta Wyska
November 1996, British journal of clinical pharmacology,
Wojciech Krzyzanski, and Elzbieta Wyska
November 2012, Anesthesia and analgesia,
Copied contents to your clipboard!