A Phase 1 interventional study of Elinzanetant (BAY3427080) and Midazolam in Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, sponsored by Bayer. Completed at 1 site in Germany. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-25.
Sponsored by Bayer · Phase 1, Interventional, and Other
Researchers are looking for a better way to treat people who have symptoms caused by hormonal changes, such as hot flashes. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to the treatment in the body.
In this study researchers want to learn more about a new substance called elinzanetant.
Elinzanetant, the study treatment, was developed to treat symptoms caused by hormonal changes, such as hot flashes. Carbamazepine is a drug that is already available for doctors to prescribe, for example against seizures. Midazolam is a treatment that is already available for doctors to prescribe as a sedative (calming treatment) or to help people sleep.
In this study, the researchers will learn how much elinzanetant gets into the participants' blood when taken with or without carbamazepine. They will also get to know if taking elinzanetant will affect the amount of midazolam in the blood.
The participants will all take elinzanetant as capsules, carbamazepine as tablets and midazolam as a liquid by mouth. On some days, they will take only 1 treatment of midazolam or carbamazepine or only elinzanetant. On other days, they will take two study treatments. On 3 different days during the study, the participants will take elinzanetant with midazolam, elinzanetant with carbamazepine and midazolam with carbamazepine.
Each participant will be in the study for up to 10 weeks. But, the entire study will last about 4 months.
During the study, all of the participants will stay at the study site for 2 periods, period 1 with 9 overnight stays and period 2 with 22 overnight stays at the study site. In addition, there will be two ambulatory visits, one before joining the study and one at the end of the study.
Blood and urine samples will be collected. The doctors will also check the participants' heart health using an electrocardiogram (ECG). The participants will answer questions about how they are feeling and about any medications they are taking.
Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria
Fixed treatment sequence starting with 2 single oral doses of midazolam and a single dose of elinzanetant.
Drug: Elinzanetant (BAY3427080) · Drug: Midazolam
Up titration of carbamazepine over 4 days (dose 1, 2, 3) continued by fixed dose 3 of carbamazepine prior to administration of midazolam / elinzanetant, followed by carbamazepine administration.
Drug: Elinzanetant (BAY3427080) · Drug: Midazolam · Drug: Carbamazepine
Elinzanetant given orally as a single dose in Period 1 and in Period 2.
Also known as: NT-814
Midazolam given orally as single dose in Period 1 and in Period 2.
Carbamazepine given orally twice daily in Period 2 .
AUC of elinzanetant with carbamazepine.
AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose.
Time frame: Period 2: Predose, Day 1 to Day 8
AUC of elinzanetant without carbamazepine.
AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose.
Time frame: Period 1: Predose, Day 1 to Day 8
Cmax of elinzanetant with carbamazepine.
Cmax: Maximum observed drug concentration in measured matrix after single dose administration.
Time frame: Period 2: Predose, Day 1 to Day 8
Cmax of elinzanetant without carbamazepine.
Cmax: Maximum observed drug concentration in measured matrix after single dose administration.
Time frame: Period 1: Predose, Day 1 to Day 8
Number of participants with treatment-emergent adverse events (TEAEs) without concomitant carbamazepine.
Time frame: After the first administration of study intervention up to 7 days after the last administration
Number of participants with TEAEs with concomitant carbamazepine.
Time frame: After the first administration of study intervention up to 7 days after the last administration
Plan to share: No — Availability of this study's data later will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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