check_circleStudy Completed
Cough, Endometriosis, Overactive bladder
Bayer Identifier:
21198
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study to gather information on the influence of BAY1817080 on the electrical activity of the heart recorded by an electrocardiogram in healthy male and female participants
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
18 - 65 YearsTrial summary
Enrollment Goal
42Trial Dates
June 2020 - January 2021Phase
Phase 1Could I Receive a placebo
YesProducts
Eliapixant (BAY1817080)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | CRS Clinical Research Services Mannheim GmbH | Mannheim, 68167, Germany |
Primary Outcome
- Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 therapeutic dosedate_rangeTime 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 dosedate_rangeTime Frame:Baseline and Day 3
Secondary Outcome
- Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after a single oral dose of moxifloxacindate_rangeTime 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 dosedate_rangeTime 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 moxifloxacindate_rangeTime Frame:Baseline and Day 3
- AUC(0-24)md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic doseArea under the concentration vs. time curve from zero to 24 hours after multiple dosesdate_rangeTime Frame:Predose and up to 24 hours after last dose of BAY1817080 at Day 3
- AUC after a single oral dose of moxifloxacinArea under the concentration vs. time curve from zero to infinity after single dosedate_rangeTime Frame:Predose and up to 24 hours after single dose of moxifloxacin at Day 3
- Cmax,md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic doseMaximum observed drug concentration in measured matrix after multiple dosesdate_rangeTime Frame:Up to 24 hours after last dose of BAY1817080 at Day 3
- Cmax after a single oral dose of moxifloxacinMaximum observed drug concentration in measured matrix after single dosedate_rangeTime 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 dosedate_rangeTime Frame:From the start of BAY1817080 administration until 7 days after last dose, assessed up to 10 days
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
N/AAssignment
Crossover AssignmentTrial Arms
4