alexa The Effects of a Meal on QTc to Demonstrate ECG Assay Sensitivity in Phase I Studies
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

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Short Communication

The Effects of a Meal on QTc to Demonstrate ECG Assay Sensitivity in Phase I Studies

Jörg Täubel1,2*, Georg Ferber3, Sara Fernandes1, Ulrike Lorch1, Mariano Sust4 and A John Camm2

1Richmond Pharmacology Ltd., St George's University of London, Cranmer Terrace, London, United Kingdom

2Cardiovascular and Cell Sciences Research Institute, St George's University of London, Cranmer Terrace, London, United Kingdom

3Statistik Georg Ferber GmbH, Cagliostrostrasse, Riehen, Switzerland

4Department of Clinical Investigation, ESTEVE Research & Development, Av. Mare de Déu de Montserrat, Barcelona, Spain

*Corresponding Author:
Dr Jörg Täubel
Richmond Pharmacology Ltd, St George’s University of London, Cranmer Terrace
SW17 0RE London, United Kingdom
Telephone: +44(0)20 8664 5200
Fax: +44(0)20 8664 5201
E-mail: [email protected]

Received date: October 24, 2016; Accepted date: October 30, 2016; Published date: November 10, 2016

Citation: Täubel J, Ferber G, Fernandes S, Lorch U, Sust M, et al. (2016) The Effects of a Meal on QTc to Demonstrate ECG Assay Sensitivity in Phase I Studies. J Bioequiv Availab 8:272-273. doi: 10.4172/jbb.1000307

Copyright: © 2016 Täubel J, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

In December 2015, the International Conference of Harmonization (ICH) E14 guideline generated guidance on how exposure-response modelling can be used to characterise the potential for a drug to affect cardiac repolarisation and to modulate the QTc interval. The released Q&A document describes how data from Phase I ascending dose SAD and MAD studies can be used in the right circumstances to be accepted by regulatory bodies as an alternative approach to TQT to demonstrate cardiac safety. While this strategy is now being expanded to all new drugs, this alternative analysis has been extensively used in the past. This commentary discusses the results of a retrospective analysis where a concentration-effect analysis validated by meal effects on the ECG was applied to a Phase I study to investigate the PK, PD and safety of escalating single doses of a highly selective sigma1 receptor antagonist.

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