Why the study?
The CiPA initiative proposes that balanced multi-ion channel-blocking drugs have low torsade risk and would not cause heart rate corrected J-Tpeak prolongation.
Does the absence of J-T peak c prolongation identify balanced multi-ion channel-blocking drugs in a Phase I study?
Population
Subjects in a Phase I study (10 subjects per drug in parallel design)
Comparison
Lopinavir/ritonavir vs verapamil vs ranolazine vs chloroquine, and diltiazem with dofetilide
Design
Phase I randomized parallel and separate crossover study
Authors
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The absence of J-T peak c prolongation appears consistent with balanced multi-ion channel block, supporting its potential utility as an ECG biomarker for proarrhythmia risk assessment.
Does the absence of J-T peak c prolongation identify balanced multi-ion channel-blocking drugs in a Phase I study?
The absence of J-T peak c prolongation appears consistent with balanced multi-ion channel block, supporting its potential utility as an ECG biomarker for proarrhythmia risk assessment.
Vicente et al. (2018) studied this question.
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