Why the study?
Can concentration-effect (CE) models in small Phase I studies reliably predict the absence of an effect on QTc?
Population
Simulated subjects subsampled from 3 different thorough QT (TQT) studies (healthy subjects)
Design
Other
Authors
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CE models with placebo in Phase I trials may exclude small QTc effects; leaves open replacement of thorough QT studies.
Can concentration-effect (CE) models in small Phase I studies reliably predict the absence of an effect on QTc?
Concentration-effect models in early Phase I studies can reliably exclude small QTc effects, potentially replacing thorough QT studies if adequately designed with placebo subjects and appropriate sampling.
Ferber et al. (2015) studied this question.
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