The effect can be measured as prolongation of the QT interval in the ECG. Since the duration of QT interval is reversely related to heart rate, different formulae for correction exist:
i) Bazett: QTc = QT/RR0.5
ii) Fridericia: QTc = QT/RR0.33
iii) Individual correction based on analysis of regression of QT and RR at various heart rates
The criteria of a negative TQT study are fulfilled when the one-sided 95% confidence interval of the mean effect on QTc interval excludes 10 ms. The TQT study should be conducted relatively early, but not before all the data are available that are needed for designing the trial. This mainly concerns information on PK and clinical dose. Inamed’s clinical development experts would be pleased to provide you further advice in this regard taking into account not only the scientific and regulatory needs, but also the principles of a cost-efficient clinical project development.
Design elements:
W. Timmer
Cardiac Safety - Dr Wolfgang Timmer examines the conduct of thorough QTc trials in practice from a Phase I CRO's perspective
European Pharmaceutical Contractor, Summer '08 Issue, Samedan Ltd. Pharmaceutical Publishers 2008
T. Spinelli, C. Moresino, S. Baumann, W. Timmer, A. Schultz
Effects of combined netupitant and palonosetron (NEPA), a cancer supportive care antiemetic, on the ECG of healthy subjects: an ICH E14 thorough QT trial SpringerPlus 2014, 3: 389. DOI: 10.1186/2193-1801-3-389
M. Hartmann, W. Timmer, A. Schultz, R. Nave, R. Lühmann, S. Krause, G. Lahu, J. Scholpp
A Thorough QT Study of Teduglutide in Healthy Subjects
Clinical Pharmacology in Drug Development 2012; 1: 57-66