Study to investigate the effect of Ritobegron CL (KUC 7483 CL) on the QT/QTc interval of the ECG in comparison to placebo and moxifloxacin
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
39
Ritobegron Cl (KUC 7483 CL) tablets low dose
Change from baseline in mean time-matched QTcI
Time frame: up to 2 hours following drug administration
Change from baseline in mean time-matched QTcI
Time frame: up to 8 hours following drug administration
Occurrence of uncorrected QT interval
QT interval \<=500 ms, \> 500 ms
Time frame: up to 8 hours following drug administration
Occurrence of the QTcI interval
QTcI interval \<= 450 ms, \>450 ms, \>480 ms or \>500 ms
Time frame: up to 8 hours following drug administration
Change from baseline of the QTcI interval
QTcI interval \< 30 ms, ≤ 60 ms
Time frame: up to 8 hours following drug administration
Change from baseline in Heart Rate (HR)
increase ≥25 % or decrease HR by ≥25 %
Time frame: up to 6 hours following drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 8 hours following drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 8 hours following drug administration
AUC0-6 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours)
Time frame: up to 6 hours following drug administration
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AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 8 hours) for moxifloxacin
Time frame: up to 8 hours following drug administration
Number of subjects with adverse events
Time frame: up to 17 days after last drug administration
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 17 days after last drug administration
Number of subjects with abnormal changes in 12-lead ECG
Time frame: up to 17 days after last drug administration
Number of patients with clinically significant changes in vital signs
Blood pressure, pulse rate
Time frame: up to 17 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: 17 days after last drug administration