A Phase 1 interventional study of Elinzanetant (BAY3427080) and Placebo in Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, sponsored by Bayer. Completed at 1 site in Japan. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-29.
Sponsored by Bayer · Phase 1, Interventional, and Other
Researchers are looking for a new way to treat women who have symptoms that are caused by the sex hormonal changes that happen when a woman's body is going through the menopause. These symptoms include Vasomotor Symptoms (VMS) (hot flashes), and changes in blood pressure. Menopause is when women stop having a menstrual cycle, also called a period. During the period, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life.
In this study, researchers want to learn more about a new substance called elinzanetant. Elinzanetant was developed to treat symptoms caused by sex hormonal changes. It works by blocking a group of proteins called neurokinins from sending signals to other parts of the body, which play a role in starting the symptoms.
In this study, the researchers will learn how safe elinzanetant is and how it affects the body of healthy Japanese women compared to a placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Before a new treatment can be given to patients, researchers do studies in healthy participants to learn more about its safety and how it acts in the body.
There will be 2 parts to this study. In Part A, the participants will take a single dose of either elinzanetant or the placebo. In Part B, the participants will take multiple doses of elinzanetant or the placebo. The participants will take each study treatment as capsules by mouth.
The main purpose of this study is to learn how safe elinzanetant is and how it affects the body. To answer this question, the researchers will collect the medical problems the participants have after receiving the treatment and that may or may not be related to the study treatment. These medical problems are also known as "adverse events".
During Part A, the participants will stay at their study site for a total of 9 days. They will take either elinzanetant or the placebo only on Day 1 of their stay. During Part B, the participants will stay at their study site for a total of 15 days. They will take either elinzanetant or the placebo once a day for 7 days of their stay. Each participant will be in the study for a total of approximately 5 weeks for Part A and approximately 6 weeks for Part B.
During the study, the doctors will:
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Exclusion Criteria:
Each participant will receive a single oral dose of elinzanetant or placebo.
Drug: Elinzanetant (BAY3427080) · Drug: Placebo
Each participant will receive a single oral dose of elinzanetant or placebo.
Drug: Elinzanetant (BAY3427080) · Drug: Placebo
Each participant will receive a single oral dose of elinzanetant or placebo.
Drug: Elinzanetant (BAY3427080) · Drug: Placebo
Each participant will receive a single oral dose of elinzanetant or placebo.
Drug: Elinzanetant (BAY3427080) · Drug: Placebo
Each participant will receive a single oral dose of elinzanetant or placebo.
Drug: Elinzanetant (BAY3427080) · Drug: Placebo
Each participant will receive multiple doses of elinzanetant or placebo administered once a day for 7 consecutive days.
Drug: Elinzanetant (BAY3427080) · Drug: Placebo
Oral administration
Oral administration
Number of participants with and severity of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 weeks after start of dosing
Cmax (maximum observed drug concentration after single dose administration) of elinzanetant
Only for single dose steps 1 to 4 and 6
Time frame: Day 1 pre-dose until 144 hours post-dose
Cmax/D (Cmax divided by dose) of elinzanetant
Only for single dose steps 1 to 4 and 6
Time frame: Day 1 pre-dose until 144 hours post-dose
AUC (area under the concentration vs. time curve from zero to infinity after single dose) of elinzanetant
Only for single dose steps 1 to 4 and 6
Time frame: Day 1 pre-dose until 144 hours post-dose
AUC/D (AUC divided by dose) of elinzanetant
Only for single dose steps 1 to 4 and 6
Time frame: Day 1 pre-dose until 144 hours post-dose
Cmax,md (maximum observed drug concentration after multiple dose administration) of elinzanetant
Only for multiple dose step 5
Time frame: Day 7 (pre-dose until 144 hours post-dose)
Cmax,md/D (Cmax,md divided by dose) of elinzanetant
Only for multiple dose step 5
Time frame: Day 7 (pre-dose until 144 hours post-dose)
AUC(0-24)md (AUC from time 0 to 24 h after multiple dose) of elinzanetant
Only for multiple dose step 5
Time frame: Day 7 (pre-dose until 24 hours post-dose)
AUC(0-24)md/D (AUC(0-24)md divided by dose) of elinzanetant
Only for multiple dose step 5
Time frame: Day 7 (pre-dose until 24 hours post-dose)
Plan to share: No — Availability of this study's data will later 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 Mar 2022. You cannot join it, but the record below documents what was studied.
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