The main objective of this trial is to evaluate the effects of verducatib in the range of therapeutic to supra-therapeutic exposures on the QT/QTc-interval and other ECG parameters
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
CRS Clinical Research Services Mannheim GmbH
Mannheim, Germany
RECRUITINGQT-interval corrected for heart rate, e.g. using the method of Fridericia change from baseline (ΔQTcF), paired with the verducatib plasma concentrations
ΔQTcF defined as the time-matched QTcF change from baseline, paired with the verducatib plasma concentrations collected at the same timepoints up to a maximum of 30 days after first drug administration of verducatib/verducatib-placebo
Time frame: Up to day 31
QT-interval corrected for heart rate, e.g. using the method of Fridericia change from baseline (ΔQTcF), paired with the moxifloxacin plasma concentrations
ΔQTcF, defined as the QTcF change from baseline, paired with the moxifloxacin plasma concentrations collected at the same timepoints up to 24 hours after a single dose administration of moxifloxacin/moxifloxacin-placebo and constitutes the assessment of assay sensitivity in this trial
Time frame: Up to day 31
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Placebo resembling Moxifloxacin