hot flashes Postmenopausal symptoms
Conditions
Interventions
Day | Treatment | Route | Timing | How often
1 | Elinzanetant 120 mg (2x60 mg soft gelatin capsules) | oral | Morning | once
| [13C5]Elinzanetant 100 µg in 10 mL over 30 minutes | intravenous
infusi
Sponsors
Bayer AG
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent. 2. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. 3. 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). 4. 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
Exclusion criteria: 1. 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. 2. 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. 3. 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. 4. 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. 5. Known hypersensitivity to the study interventions (active substances, or excipients of the preparations). 6. 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. 7. Relevant diseases within the last 4 weeks prior to the first study intervention administration. 8. Febrile illness within 4 weeks before first study intervention administration. 9. Contraindications for the use of esomeprazole, especially known hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency 10. Use of drugs which may affect absorption (e.g. loperamide, metoclopramide) within 1 week before first study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the effect of multiple doses of esomeprazole on the PK of elinzanetant | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the safety and tolerability of elinzanetant To determine the absolute bioavailability of elinzanetant after single oral administration of elinzanetant together with an IV microtracer dose of [13C5]BAY3427080 | — |
Countries
Netherlands
Outcome results
None listed