Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
Hot Flashes
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Researchers are looking for a better way to treat men and women with vasomotor symptoms, a condition of having hot flashes caused by hormonal changes. The study treatment, elinzanetant, is under deve...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05351892
Start Date
May 4 2022
End Date
June 20 2022
Last Update
July 19 2022
Active Locations (1)
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1
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States, 33014