A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults

This is an interventional other trial for Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men focused on measuring Hot flushes, Vasomotor symptoms, Elinzanetant, Drug-drug interaction, Proton pump inhibitor, Pharmcokinetics Read More

Inclusion Criteria:

• Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
• Body weight of at least 50 kg and body mass index (BMI) within the range of 18.0 to 30.0 kg/m^2 (inclusive).

• Male and female Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

  • Male participants: Male participants of reproductive potential must agree to use a condom (with or without spermicide) when sexually active. This applies for the time period between the signing of the informed consent form (ICF) until 5 days after the last dose of study intervention. Female partners of childbearing potential of male participants do not need to follow special precautions.
  • Female participants: Women of childbearing potential will have to use highly effective non-hormonal contraception when having sexual intercourse with a male partner from signing the ICF until 5 days after last dose of the study drug.
  • Women of non-childbearing potential are not required to use contraception. Non-childbearing potential is defined as
• Postmenopausal state confirmed by follicle stimulating hormone (FSH) level >33.4 U/L, or above reference range from the local laboratory, or
• Surgically sterilized by bilateral tubal ligation, bilateral oophorectomy with or without hysterectomy, or hysterectomy documented by medical report verification.

Exclusion Criteria:

• Any clinically relevant abnormal findings in medical history and physical examination which in the opinion of the investigators, may put the participant at risk because of his/her participation in the trial or provide difficulties in interpreting the trial data.
• History or evidence of any clinically relevant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other clinically relevant disease, as judged by the investigator.
• 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.
• Any medical disorder, condition or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator.
• 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 non-allergic drug reactions.
• Relevant diseases within the last 4 weeks prior to the first study intervention administration.
• Febrile illness within 4 weeks before first study intervention administration.
• Contraindications for the use of esomeprazole, especially known hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
• Use of drugs which may affect absorption (e.g. loperamide, metoclopramide) within 1 week before first study drug administration.