A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male Participants

Launched by BAYER · Apr 25, 2022

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Participant must be 18 to 45 years of age inclusive, at the time of signing the informed consent.
• • Participants who are overtly healthy as determined by medical evaluation of the investigator, including medical history, physical examination, blood pressure, pulse rate, body temperature, laboratory tests, and cardiac monitoring
• • Body weight of at least 50 kg and body mass index (BMI) within the range 18 to 30 kg/m\^2 (inclusive)
• • Male or female
• • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Exclusion Criteria:
• • Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal
• • Known or suspected allergy or hypersensitivity to elinzanetant or any of their excipients
• • Any history of or ongoing endocrine disease
• • Any known impairment of testosterone synthesis and metabolism
• • Poor venous access
• • History of alcohol or drug abuse
• • Regular use of prescription drugs, over-the-counter drugs, supplements (e.g. carnitine products, anabolics, high dose vitamins) or herbal products within 2 weeks or 5 half-lives (whichever longer) prior to the first study intervention administration
• • Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks prior to the first study intervention administration, e.g. any investigational drug, any CYP3A4 inducers including St John's Wort, any proton pump inhibitors, or any other drug known to induce liver enzymes (e.g. dexamethasone, barbiturates), and 2 weeks for any drug known to inhibit liver enzymes (e.g. itraconazole, macrolides) as well as grapefruit.
• • Clinically relevant findings in the Electrocardiogram (ECG), such as second or third degree AV block, prolongation of ECG parameters (QTcF \> 450 msec, QRS \> 120 msec)
• • Clinically relevant deviations of the screened laboratory parameters from reference ranges at screening or Day -1.