Testing the nonclinical Comprehensive In Vitro Proarrhythmia Assay (CiPA) paradigm with an established anti-seizure medication: Levetiracetam case study.
CiPA
ICH S7B
QT prolongation
cardiac safety
levetiracetam
nonclinical
torsade de pointes
Journal
Pharmacology research & perspectives
ISSN: 2052-1707
Titre abrégé: Pharmacol Res Perspect
Pays: United States
ID NLM: 101626369
Informations de publication
Date de publication:
02 2023
02 2023
Historique:
revised:
12
01
2023
received:
01
08
2022
accepted:
13
01
2023
entrez:
7
2
2023
pubmed:
8
2
2023
medline:
9
2
2023
Statut:
ppublish
Résumé
Levetiracetam (LEV), a well-established anti-seizure medication (ASM), was launched before the original ICH S7B nonclinical guidance assessing QT prolongation potential and the introduction of the Comprehensive In Vitro Proarrhythmia Assay (CiPA) paradigm. No information was available on its effects on cardiac channels. The goal of this work was to "pressure test" the CiPA approach with LEV and check the concordance of nonclinical core and follow-up S7B assays with clinical and post-marketing data. The following experiments were conducted with LEV (0.25-7.5 mM): patch clamp assays on hERG (acute or trafficking effects), Na
Identifiants
pubmed: 36748725
doi: 10.1002/prp2.1059
pmc: PMC9903303
doi:
Substances chimiques
Levetiracetam
44YRR34555
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e01059Subventions
Organisme : Wellcome Trust
Pays : United Kingdom
Informations de copyright
© 2023 UCB Biopharma SRL. Pharmacology Research & Perspectives published by British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics and John Wiley & Sons Ltd.
Références
Toxicol Sci. 2022 Apr 26;187(1):3-24
pubmed: 35148401
Chest. 1996 May;109(5):1215-21
pubmed: 8625670
J Pharmacol Toxicol Methods. 2020 Sep;105:106900
pubmed: 32768644
Cardiovasc Res. 2003 Apr 1;58(1):32-45
pubmed: 12667944
Epilepsia. 2010 Feb;51(2):233-42
pubmed: 19817816
Am J Cardiol. 1992 Mar 1;69(6):628-33
pubmed: 1536113
Fed Regist. 2005 Oct 20;70(202):61134-5
pubmed: 16237860
Br J Pharmacol. 2010 Jan;159(1):115-21
pubmed: 19785646
Epilepsy Curr. 2009 Jul-Aug;9(4):91-5
pubmed: 19693322
PLoS Comput Biol. 2011 May;7(5):e1002061
pubmed: 21637795
Eur J Pharmacol. 1998 Jul 24;353(2-3):191-206
pubmed: 9726649
ChemMedChem. 2008 Oct;3(10):1501-2
pubmed: 18696522
Pharmacol Res Perspect. 2023 Feb;11(1):e01059
pubmed: 36748725
Am J Cardiol. 1984 Jul 1;54(1):103-8
pubmed: 6741799
Fed Regist. 2005 Oct 20;70(202):61133-4
pubmed: 16237859
Eur J Clin Invest. 2003 Feb;33(2):93-8
pubmed: 12588281
Eur J Pharm Sci. 2009 Jan 31;36(1):62-77
pubmed: 19061955
Pract Neurol. 2019 Feb;19(1):56-61
pubmed: 30323052
Front Physiol. 2017 Aug 23;8:616
pubmed: 28878692
Expert Opin Drug Saf. 2014 Jun;13(6):745-58
pubmed: 24845945
Clin Ther. 2006 May;28(5):734-44
pubmed: 16861095
Seizure. 2015 Jul;29:134-6
pubmed: 26076856
Prog Biophys Mol Biol. 2016 Jan;120(1-3):115-27
pubmed: 26701222
Front Pharmacol. 2020 Jan 30;10:1643
pubmed: 32082155
Elife. 2019 Dec 24;8:
pubmed: 31868580
Proc Natl Acad Sci U S A. 2013 Jun 4;110(23):E2098-105
pubmed: 23690584
Am J Cardiol. 2003 Apr 1;91(7):916-9
pubmed: 12667592
Clin Transl Sci. 2021 May;14(3):1133-1146
pubmed: 33620150
Cerebrovasc Dis. 2006;21(1-2):47-53
pubmed: 16282690
Front Physiol. 2017 Sep 12;8:668
pubmed: 28955244
Br J Pharmacol. 2019 Oct;176(19):3819-3833
pubmed: 31271649
ScientificWorldJournal. 2012;2012:212178
pubmed: 22593664
Clin Ther. 2008 Feb;30(2):260-70
pubmed: 18343264
Nat Rev Drug Discov. 2016 Jul;15(7):457-71
pubmed: 26893184
J Cardiovasc Pharmacol. 2001 May;37(5):607-18
pubmed: 11336111
Br J Pharmacol. 2010 Jan;159(1):102-14
pubmed: 19673885
Sci Rep. 2013;3:2100
pubmed: 23812503