Key result
A planned randomized study of 20 healthy subjects will evaluate whether early QT assessment using exposure-response analysis of 6 marketed drugs can replace the thorough QT study.
Why the study?
Can early QT assessment using exposure response analysis replace the thorough QT study in healthy subjects?
Population
20 healthy subjects
Comparison
Six marketed drugs with well-characterized QTc… vs Placebo (6 subjects)
Design
Other, randomized, placebo-controlled
Authors
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This study protocol outlines a design to determine if robust ECG monitoring and exposure-response analysis in early Phase 1 studies can replace the thorough QT study.
RCT (n=20)
randomized
Can early QT assessment using exposure response analysis replace the thorough QT study in healthy subjects?
This study protocol outlines a design to determine if robust ECG monitoring and exposure-response analysis in early Phase 1 studies can replace the thorough QT study.
Darpö et al. (2013) conducted an RCT in Healthy subjects (n=20). Six marketed drugs with well-characterized QTc effects vs. Placebo was evaluated on Projected QTc effect at peak plasma level. A planned randomized study of 20 healthy subjects will evaluate whether early QT assessment using exposure-response analysis of 6 marketed drugs can replace the thorough QT study.
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