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CiPA Phase 1 ECG Biomarker Validation Study

Food and Drug Administration (FDA) · 2017
ClinicalTrials.gov · Datasets · License: Public Domain · 2017
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pharmacodynamicspharmacokinetics
This study will assess whether exposure response analysis of the electrocardiographic QTc and J-Tpeakc intervals in Phase 1 clinical pharmacology studies can be used to confirm that drugs that predominantly block the potassium channel encoded by the human ether-à-go-go-related gene (hERG) with approximately equipotent late sodium and/or calcium block ("balanced ion channel" drugs) do not cause J-Tpeakc prolongation and that drugs that predominantly block hERG without late sodium or L-type calcium current block ("predominant hERG" drugs) cause QTc prolongation.
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