CRS Clinical Research Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, 68167, Germany
NCT Number: NCT04423744
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Mannheim, Baden-Wurttemberg, 68167, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Film-coated tablet
Film-coated tablet
Matched placebo as film-coated tablet
Time frame: Baseline and Day 3
Time frame: Baseline and Day 3
Time frame: Baseline and Day 3
Time frame: Baseline and Day 3
Time frame: Baseline and Day 3
Time frame: Predose and up to 24 hours after last dose of BAY1817080 at Day 3
Area under the concentration vs. time curve from zero to 24 hours after multiple doses
Time frame: Predose and up to 24 hours after single dose of moxifloxacin at Day 3
Area under the concentration vs. time curve from zero to infinity after single dose
Time frame: Up to 24 hours after last dose of BAY1817080 at Day 3
Maximum observed drug concentration in measured matrix after multiple doses
Time frame: Up to 24 hours after single dose of moxifloxacin at Day 3
Maximum observed drug concentration in measured matrix after single dose
Time frame: From the start of BAY1817080 administration until 7 days after last dose, assessed up to 10 days
Bayer
Industry
Randomized, Single-blind, Double-dummy, 4-fold Cross-over, Placebo- and Active-controlled Study to Investigate the Influence of BAY 1817080 on the QTc Interval in Healthy Male and Female Participants (TQT Study)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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