In this study, researchers want to find whether the study drug BAY1817080 has an effect on the electrocardiogram (ECG). 40 healthy male or female participants with the age of 18 to 65 years will be enrolled into this study. The ECG of the participants will be monitored closely by the researchers to detect any change after intake of the study medication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
42
Film-coated tablet
Film-coated tablet
Matched placebo as film-coated tablet
CRS Clinical Research Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany
Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 therapeutic dose
Time frame: Baseline and Day 3
Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 supra-therapeutic dose
Time frame: Baseline and Day 3
Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after a single oral dose of moxifloxacin
Time frame: Baseline and Day 3
Time-matched, placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) and Bazett (QTcB) after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose
Time frame: Baseline and Day 3
Time-matched, placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) and Bazett (QTcB) after a single oral dose of moxifloxacin
Time frame: Baseline and Day 3
AUC(0-24)md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose
Area under the concentration vs. time curve from zero to 24 hours after multiple doses
Time frame: Predose and up to 24 hours after last dose of BAY1817080 at Day 3
AUC after a single oral dose of moxifloxacin
Area under the concentration vs. time curve from zero to infinity after single dose
Time frame: Predose and up to 24 hours after single dose of moxifloxacin at Day 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cmax,md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose
Maximum observed drug concentration in measured matrix after multiple doses
Time frame: Up to 24 hours after last dose of BAY1817080 at Day 3
Cmax after a single oral dose of moxifloxacin
Maximum observed drug concentration in measured matrix after single dose
Time frame: Up to 24 hours after single dose of moxifloxacin at Day 3
Incidences of treatment-emergent adverse events (TEAEs) after BAY1817080 therapeutic or supra-therapeutic dose
Time frame: From the start of BAY1817080 administration until 7 days after last dose, assessed up to 10 days