Why the study?
Following the 2015 ICH E14 revision allowing concentration-corrected QT interval analysis in early clinical studies to obviate designated thorough QT studies, the review shares practical examples of its implementation in first-in-human studies.
Can concentration-corrected QT interval (C-QTc) analysis in early clinical pharmacology studies effectively evaluate drug-induced QTc prolongation and obviate the need for thorough QT studies?
Can concentration-corrected QT interval (C-QTc) analysis in early clinical pharmacology studies effectively evaluate drug-induced QTc prolongation and obviate the need for thorough QT studies?
Concentration-corrected QTc analysis in first-in-human studies offers a viable strategy to evaluate drug-induced QT prolongation and reduce the need for dedicated thorough QT studies.
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C-QTc in FIH studies may waive TQT requirements; leaves open generalizability across drug classes and populations.
Darpö et al. (2022) studied this question.
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