Literature DB >> 23649000

The anesthetized guinea pig: an effective early cardiovascular derisking and lead optimization model.

Pierre Morissette1, Masahiro Nishida, Elena Trepakova, John Imredy, Armando Lagrutta, Alysia Chaves, Kimberly Hoagland, Chao-Min Lei Hoe, Matthew M Zrada, Jeffrey J Travis, Gloria J Zingaro, Pamela Gerenser, Greg Friedrichs, Joseph J Salata.   

Abstract

INTRODUCTION: In recent years, the anesthetized guinea pig has been used increasingly to evaluate the cardiovascular effects of drug-candidate molecules during lead optimization prior to conducting longer, more resource intensive safety pharmacology and toxicology studies. The aim of these studies was to evaluate the correlations between pharmacologically-induced ECG changes in the anesthetized cardiovascular guinea pig (CVGP) with ECG changes in conscious non-rodent telemetry models, human clinical studies and effects on key cardiac ion channels.
METHODS: We compared the effects of 38 agents on ion channel inhibition to their ECG effects in the CVGP. 26 of these agents were also evaluated in non-rodent telemetry and compared to the results in the CVGP.
RESULTS: The CVGP was highly sensitive for detecting QTc, PR and QRS interval prolongation mediated by inhibition of hERG, hCav1.2 and hNav1.5, respectively. There were robust correlations between ion channel inhibitory potencies and the free plasma concentrations (Cu) producing prolongation of the QTc, PR or QRS interval. Further evaluation showed that ECG changes in the CVGP were predictive of their effects on the QTc, PR and QRS intervals in non-rodent telemetry models with 92%, 92% and 100% accuracy, respectively. The CVGP proved to be 100% specific and 88%, 75% and 100% sensitive for QTc, PR and QRS interval prolongation, respectively. Similarly, the Cu that prolonged the QTc, PR and QRS in CVGP and humans correlated well. DISCUSSION: The CVGP is a sensitive model for assessing QTc, PR and QRS prolongation elicited by effects on hERG, hCav1.2 and hNav1.5, respectively. ECG changes in the CVGP are predictive of changes in non-rodent telemetry models and in humans (QTc). ECG parameters can be reliably evaluated with the CVGP model which increases the efficiency of CV derisking. Importantly, the design and implementation of this model is consistent with the "3Rs" for animal research.
Copyright © 2013 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  3Rs; Anesthetized guinea pig; Assay sensitivity and specificity; CVGP; Cu; ECG; GP; ICH S7A and S7B; IKr; IKs; In vivo assay performance; NCE; Non-rodent telemetry; PPB; QTc; Safety pharmacology; TdP; Translation; anesthetized cardiovascular guinea pig; free plasma concentration; guinea pig; hCav1.2; hERG; hNav1.5; human L-type calcium current; human cardiac Na+ channel α-subunit; human ether-a-go-go related gene; new chemical entity; plasma protein binding; rapidly activating delayed rectifier potassium current; slowly activating delayed rectifier potassium current; the heart rate corrected QT interval; torsades de pointes

Mesh:

Substances:

Year:  2013        PMID: 23649000     DOI: 10.1016/j.vascn.2013.04.010

Source DB:  PubMed          Journal:  J Pharmacol Toxicol Methods        ISSN: 1056-8719            Impact factor:   1.950


  6 in total

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Authors:  S Y A Cheung; J Parkinson; U Wählby-Hamrén; C D Dota; Å M Kragh; L Bergenholm; T Vik; T Collins; C Arfvidsson; C E Pollard; H K Tomkinson; B Hamrén
Journal:  J Pharmacokinet Pharmacodyn       Date:  2018-05-07       Impact factor: 2.745

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5.  Combining an in silico proarrhythmic risk assay with a tPKPD model to predict QTc interval prolongation in the anesthetized guinea pig assay.

Authors:  Pierre Morissette; Sebastian Polak; Anne Chain; Jin Zhai; John P Imredy; Mary Jo Wildey; Jeffrey Travis; Kevin Fitzgerald; Patrick Fanelli; Elisa Passini; Blanca Rodriguez; Frederick Sannajust; Christopher Regan
Journal:  Toxicol Appl Pharmacol       Date:  2020-01-23       Impact factor: 4.219

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Authors:  Christopher W McAleer; Amy Pointon; Christopher J Long; Rocky L Brighton; Benjamin D Wilkin; L Richard Bridges; Narasimham Narasimhan Sriram; Kristin Fabre; Robin McDougall; Victorine P Muse; Jerome T Mettetal; Abhishek Srivastava; Dominic Williams; Mark T Schnepper; Jeff L Roles; Michael L Shuler; James J Hickman; Lorna Ewart
Journal:  Sci Rep       Date:  2019-07-03       Impact factor: 4.379

  6 in total

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