IndraLab

"A retrospective analysis of 34 TQT studies40 followed by two prospective clinical trials22, 41 including eight drugs demonstrated that drugs that predominantly block hERG prolong QTc by prolonging both J-Tpeakc (early repolarization) and Tpeak-Tend (late repolarization), while drugs that block hERG along with calcium and/or late sodium (balanced ion channel block) prolonged QTc by prolonging Tpeak-Tend with no or limited effect on the J-Tpeakc interval.22, 40, 41 Figure XREF_FIG b shows data from the first prospective clinical trial,41 where dofetilide (predominant hERG blocker) prolonged QTc by prolonging both J-Tpeakc and Tpeak-Tend."

"The primary objectives of the study are : To confirm that exposure response analysis of the electrocardiographic QTc and J-Tpeakc intervals in phase I clinical pharmacology studies can be used to confirm that balanced ion channel blocking drugs do not cause J-Tpeakc prolongation and predominant hERG blocking drugs cause QTc prolongation."