A Trial to Learn How a New Liquid Form of BAY1817080 is Tolerated and Taken up by the Body of Healthy Male Participants (Part A). By Labeling BAY1817080 With a Radioactive Substance (Carbon 14) Researchers Want to Learn How the Study Drug is Processed and Excreted by the Body After Dosing (Part B)

This is an interventional basic science trial for Endometriosis Related Pain focused on measuring Healthy volunteers, Pharmacokinetics (PK) Read More

Inclusion Criteria:

• Capable of giving signed informed consent as described in Appendix which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol;
• Ability to understand and follow study-related instructions;
• Participant has signed the ICF before any study specific tests or procedures are done;
• Healthy male participant;
• Age: 18 to 54 years (inclusive) at the time of informed consent and first dose of study medication;
• Body mass index (BMI) ≥18 and ≤30 kg/m^2 at Screening;
• Body weight of at least 45 kg at Screening;
• Participant agrees to use contraception as described in Appendix.

Exclusion Criteria:

• Presence or history of clinically relevant cardiovascular, central nervous system (CNS), hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash;
• Known hypersensitivity to the study drugs (active substances or excipients of the preparations);
• Known severe allergies, e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract (e.g., allergic asthma), allergies requiring therapy with corticosteroids or significant nonallergic drug reactions;
• Febrile illness within 1 week before study drug administration;
• Current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent occurrence of heartburn [more than once per week], or any gastrointestinal surgical intervention [e.g. cholecystectomy]);
• Participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Screening;
• Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of study intervention will not be normal;
• Poor peripheral venous access;
• Regular use of medicines within 14 days prior to administration of study intervention;
• Regular use of therapeutic or recreational drugs, e.g., cannabis, carnitine products, anabolics, high dose vitamins within 3 months prior to screening;
• Any use of medicines or substances within 14 days prior to administration, which oppose the study objectives or might affect the PK of BAY1817080 (e.g., laxatives, loperamide, metoclopramide, antacids, H2-receptor antagonists, systemic antibiotics, CYP3A4 inducers, CYP3A4 inhibitors, "organic anion transporting polypeptide" (OATP) / "breast cancer resistance protein" (BCRP) substrates, P-gp substrates and inhibitors). Relevant medication of individual participants will be discussed with the study medical expert before first dosing in the study.