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Target-Mediated Drug Disposition-A Class Effect of Soluble Epoxide Hydrolase Inhibitors
Journal article   Open access   Peer reviewed

Target-Mediated Drug Disposition-A Class Effect of Soluble Epoxide Hydrolase Inhibitors

Guohua An, Kin Sing Stephen Lee, Jun Yang and Bruce D Hammock
Journal of clinical pharmacology, Vol.61(4), pp.531-537
04/2021
DOI: 10.1002/jcph.1763
PMCID: PMC7969377
PMID: 33078430
url
https://www.ncbi.nlm.nih.gov/pmc/articles/7969377View
Open Access

Abstract

Pharmacological target-mediated drug disposition (TMDD) represents a special source of nonlinear pharmacokinetics, and its occurrence in large-molecule compounds has been well recognized because numerous protein drugs have been reported to have TMDD due to specific binding to their pharmacological targets. Although TMDD can also happen in small-molecule compounds, it has been largely overlooked. In this mini-review, we summarize the occurrence of TMDD that we discovered recently in a series of small-molecule soluble epoxide hydrolase (sEH) inhibitors. Our journey started with an accidental discovery of target-mediated kinetics of 1-(1-propanoylpiperidin-4-yl)-3-[4-(trifluoromethoxy)phenyl]urea (TPPU), a potent sEH inhibitor, in a pilot clinical study. To confirm what we observed in humans, we conducted a series of mechanism experiments in animals, including pharmacokinetic experiments using sEH knockout mice as well as in vivo displacement experiments with co-administration of another potent sEH inhibitor. Our mechanism studies confirmed that the TMDD of TPPU is due to its pharmacological target sEH. We further expanded our evaluation to various other sEH inhibitors and found that TMDD is a class effect of this group of small-molecule sEH inhibitors. In addition to summarizing the occurrence of TMDD in sEH inhibitors, in this mini-review we also highlighted the importance of recognizing TMDD of small-molecule compounds and its impact in clinical development as well as using pharmacometric modeling in facilitating quantitative understanding of TMDD.
Animals Epoxide Hydrolases - antagonists & inhibitors Humans Phenylurea Compounds - pharmacokinetics Piperidines - pharmacokinetics

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