Heart Failure
Conditions
Interventions
Depending on the group in which the volunteer will participate, the study
compound will be given once either as a tablet or as an oral solution with a
maximum of 20 milliliter (mL), depending on the
Sponsors
Bayer AG
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Healthy male participants - Age: 18 to 50 years of age (inclusive), at the time of signing the informed consent - Race: White - Body mass index (BMI) within the range of 18-29.9 kg/m2 (inclusive) at the time of screening. - The informed consent must be signed before any study specific tests or procedures are done
Exclusion criteria
Exclusion criteria: 1. Medical disorder, condition or history of such that would impair the participant*s ability to take part in or complete this study in the opinion of the investigator 2. A history of relevant or ongoing diseases such as: - respiratory tract: e.g. asthma, any airway obstruction - central nervous system: e.g. seizures, cerebrovascular malformations (e.g. aneurysm), psychiatric or neurological disorders - gastrointestinal tract: e.g. gallstones, any obstruction of the intestinum/ intestinal glands (e.g. pancreas), peptic ulcer - urinary tract: e.g. nephrolithiasis, any obstruction of the urinary passage 3. Any condition for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal 4. Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study - including e.g. non-investigational medicinal products, challenge agents, or rescue medication 5. 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 non-allergic drug reactions. For the complete overview, see the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Investigate the safety and tolerability of BAY 2413555 after single oral dosing in healthy participants (Number and percentage of participants with TEAEs) - Investigate the pharmacokinetics of BAY 2413555 (Cmax, AUC, Cmax/D, AUC/D of BAY 2413555 (if AUC cannot be determined reliably in all participants, AUC(0-tlast) will be used instead)) | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigate the pharmacodynamics of BAY 2413555 (Heart rate over 1 min over time (0-6 hours, adjusted for pre-dosing day and placebo) | — |
Countries
Netherlands
Outcome results
None listed