Why the study?
Does detailed ECG monitoring in a first-in-man single-ascending-dose study provide accurate QT interval measurements compared to placebo?
Population
48 male volunteers (6 cohorts of 8 subjects each)
Comparison
Active compound (single-ascending-dose) vs Placebo
Design
Other
Follow-up
up to day 2
Authors
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Supports omitting dedicated TQT studies when FIM ECG meets regulatory QT thresholds; extends evidence for integrated early-phase QT assessment.
Does detailed ECG monitoring in a first-in-man single-ascending-dose study provide accurate QT interval measurements compared to placebo?
Detailed ECG monitoring during a first-in-man study can provide QT interval data of regulatory acceptable accuracy, potentially avoiding the need for a separate thorough QT study.
Malík et al. (2008) studied this question.
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