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Thorough QT/QTc study

ICH E14 provides recommendations to sponsors concerning the design, conduct, analysis and interpretation of clinical studies to assess the potential of a drug to delay cardiac repolarization. Specifically, it calls for a clinical thorough QT/QTc study (typically conducted in healthy volunteers), which is intended to determine whether a drug has a threshold pharmacological effect on cardiac repolarization, as detected by QT/QTc interval prolongation. [Pg.67]

Table 3.4 Problems encountered in conducting the thorough QT/QTc study in adult healthy volunteers. Table 3.4 Problems encountered in conducting the thorough QT/QTc study in adult healthy volunteers.
The guideline acknowledges that there could be very unusual cases in which the thorough QT/QTc study is negative but the available nonclinical data are strongly positive (e.g. hERG positive at low concentrations and in vivo animal model results... [Pg.74]

Another unanswered question is the evaluation of the effect on cardiac repolarization of oncologic drugs, for which the thorough QT/QTc study in volunteers cannot be performed [166], In these cases, not only central tendency (i.e. mean QTc increase) and proportion of outliers but also other findings such as syncope, ventricular tachyarrhythmias and other cardiac effects should be more closely defined. [Pg.76]

Dixon R, Job S, OUver R, Tompson D, Wright JG, Maltby K, Torch U, Taubel J. Lamotrigine does not prolong QTc in a thorough QT/QTc study in healthy subjects. Br J Clin Pharmacol 2008 66(3) 396-404. [Pg.127]

Zhang J, Machado SG (2008) Statistical issues including design and sample size calculations in thorough QT/QTc studies. J Biopharm Stat 18 451 67... [Pg.114]

The Proarrhythmic Cardiac Safety Regulatory Landscape Circa 2005-2015 Drug-Induced hERG Channel Block and the Thorough QT/QTc Study... [Pg.137]

Table 7.1 Timeline of important events in the evolution and employment of the thorough QT/QTc study as described in ICH Guideline E14... Table 7.1 Timeline of important events in the evolution and employment of the thorough QT/QTc study as described in ICH Guideline E14...
FDA established its QT interdisciplinary review team (IRT), which reviews protocols and study reports for thorough QT/QTc studies and advises review divisions accordingly... [Pg.139]

Bouvy JC, Koopmanschap MA, Shah RR, ScheUekens H (2012) The cost-effectiveness of drug regulation the example of thorough QT/QTc studies. Qin Pharmacol Ther 91 281-288... [Pg.157]

Salvi V, Karnad DR, Kerkar V et al (2014) Comparison of two methods of estimating reader variability in QT interval measurements in thorough QT/QTc studies. Ann Noninvasive Electrocardiol 19 182-189... [Pg.159]

Sano M, Aizawa Y, Katsumata Y et al (2014) Evaluation of differences in automated QT/QTc measurements between Fukuda Denshi and Nihon Koden systems. PLoS One 9 e 106947 Satin LZ, Durham TA, Turner JR (2011) Assessing a dmg s proarrhythmic liability an overview of computer simulation modeling, nonclinical assays, and the thorough QT/QTc Study. Drug Inf J 45 357-375... [Pg.159]

Taubel J, Naseem A, Harada T et al (2010) Levofloxacin can be used effectively as a positive control in thorough QT/QTc studies in healthy volunteers. Br J Clin Pharmacol 69 391-400 Taubel J, Wong AH, Naseem A, Ferber G, Camm AJ (2012) Shortening of the QT interval after food can be used to demonstrate assay sensitivity in thorough QT studies. J Clin Pharmacol 52 1558-1565... [Pg.159]

Davy M, Upward J, Arumugham T et al (2013) Cmdiac repoleuization with gabapentin enacarbil in a randomized, double-bhnd, placebo- and active-controlled, crossover thorough QT/QTc study in healthy adults. Clin Ther 35 1964—1974... [Pg.161]

Hosmane B, Locke C, Chiu YL (2010) Exposure-response modeling approach for assessing QT effect in thorough QT/QTc studies. J Biopharm Stat 20 615-631 Huh Y, Hutmacher MM (2015) Evaluating the use of linear mixed-effect models for inference of the concentration-QTc slope estimate as a surrogate for a biological QTc model. CPT Pharmacometrics Syst Pharmacol 4 e00014... [Pg.180]

Darpo B (2010) The thorough QT/QTc study four years after the implementation of the ICH E14 1452 guidance. Br J Clin Pharmacol 159(l) 49-57... [Pg.41]

Sun GG, Quan H, Kringle R, Meng Z (2012) Comparison of statistical models adjusting for baseline in the analysis of parallel-group thorough QT/QTc studies. J Biopharm Stat 22 438-462... [Pg.467]

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