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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | 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
