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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Cough, Endometriosis, Overactive Bladder

Intervention / Treatment
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* Drug: BAY1817080
* Drug: Moxifloxacin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men must be 18 to 65 years of age inclusive, women must be 40 to 65 years of age inclusive at the time of signing the informed consent Female participants have to be in postmenopausal state Body mass index (BMI) within the range 18.0-32.0 kg/m^2 (inclusive) Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG, and vital signs 12-lead electrocardiogram recording without signs of clinically relevant pathology Exclusion Criteria: A history of relevant diseases of vital organs, of the central nervous system or other organs Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal Known hypersensitivity to the study interventions (active substances, or excipients of the preparations) Known severe allergies e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids, urticaria or significant nonallergic drug reactions Febrile illness within 1 week before study intervention administration Known or suspected disorder of the liver (e.g. bile secretion/flow disorder, Morbus Meulengracht (Gilbert´s syndrome), drug-induced hepatitis etc.) History of disorder of the pancreas or evidence for past or present pancreas disorders indicated by clinically relevant lipase or amylase levels above ULN and typical clinical symptoms of pancreas disorders as e.g. upper abdominal pain spread to the back, weight loss, fatty or pale stools Participants with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening (inclusion with normal fT3/fT4 levels allowed) History of known or suspected malignant tumors History of hypokalemia Use of CYP3A4 inhibitors from 14 days before study intervention administration until the last study visit Use of CYP3A4 inducers within 4 weeks (or at least five half-lives of the active substance whatever is longer) prior to study intervention administration Smoking more than 10 cigarettes daily Suspicion of drug or alcohol abuse Plasmapheresis within 3 months prior to study drug administration Excluded physical therapies that might alter the PK or safety results of the study (e.g. physiotherapy, acupuncture, etc.) from 7 days before first study drug administration until follow-up Systolic blood pressure below 100 mmHg or above 140 mmHg at screening. Difference of systolic BP between both arms >15 mmHg Diastolic blood pressure below 50 mmHg or above 90 mmHg at screening Heart rate below 50 beats/ min or above 90 beats/ min at screening History of COVID-19 Prior contact with SARS-CoV-2 positive or COVID-19 patient within the last 4 weeks prior admission to the ward Positive SARS-CoV-2 viral test

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention ABCD<br>Intervention A: Day 1 and 2: Supra-therapeutic dose of BAY1817080, three times daily (tid) Day 3: Supra-therapeutic dose of BAY1817080 and placebo to moxifloxacin, once Intervention B: Day 1 and 2: therapeutic dose of BAY1817080 and placebo to BAY1817080, tid Day 3: therapeutic dose of BAY1817080, placebo to BAY1817080 and placebo to moxifloxacin, once Intervention C: Day 1 and 2: Placebo to BAY1817080, tid Day 3: Placebo to BAY1817080 and moxifloxacin, once Intervention D: Day 1 and 2: Placebo to BAY1817080, tid Day 3: Placebo to BAY1817080 and placebo to moxifloxacin, once Subjects will receive intervention A, B, C and D sequentially. The washing-out period between each intervention is at least 14 days | Drug: BAY1817080<br>* Film-coated tablet<br>Drug: Moxifloxacin<br>* Film-coated tablet<br>Drug: Placebo<br>* Matched placebo as film-coated tablet<br>|
| Experimental: Intervention BCDA<br>Subjects will receive intervention B, C, D and A sequentially. The washing-out period between each intervention is at least 14 days | Drug: BAY1817080<br>* Film-coated tablet<br>Drug: Moxifloxacin<br>* Film-coated tablet<br>Drug: Placebo<br>* Matched placebo as film-coated tablet<br>|
| Experimental: Intervention CDAB<br>Subjects will receive intervention C, D, A and B sequentially. The washing-out period between each intervention is at least 14 days | Drug: BAY1817080<br>* Film-coated tablet<br>Drug: Moxifloxacin<br>* Film-coated tablet<br>Drug: Placebo<br>* Matched placebo as film-coated tablet<br>|
| Experimental: Intervention DABC<br>Subjects will receive intervention D, A, B and C sequentially. The washing-out period between each intervention is at least 14 days Note: the intervention sequences in this and above arms are examples, the actual order of intervention may differ from these examples | Drug: BAY1817080<br>* Film-coated tablet<br>Drug: Moxifloxacin<br>* Film-coated tablet<br>Drug: Placebo<br>* Matched placebo as film-coated tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 therapeutic dose |  | 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 |  | Baseline and Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after a single oral dose of moxifloxacin |  | 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 |  | 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 |  | 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 | 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 | 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 dose | Maximum observed drug concentration in measured matrix after multiple doses | 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 | 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 |  | From the start of BAY1817080 administration until 7 days after last dose, assessed up to 10 days |