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Neurokinin Antagonist

A Study to Learn How Safe Elinzanetant is, How it Affects the Body, and How it Moves Into, Through and Out of the Body After Single and Multiple Doses in Japanese Healthy Female Adults

Fukuoka, Japan
Phase 1
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7 (pre-dose until 144 hours post-dose)

Summary

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: * take blood and urine samples; * check the participants' health; * ask the participants questions about what medicines they are taking and if they are having adverse events.

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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7 (pre-dose until 144 hours post-dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 (pre-dose until 144 hours post-dose) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
AUC (area under the concentration vs. time curve from zero to infinity after single dose) of elinzanetant
AUC(0-24)md (AUC from time 0 to 24 h after multiple dose) of elinzanetant
AUC(0-24)md/D (AUC(0-24)md divided by dose) of elinzanetant
+5 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Elinzanetant single dose step 6Experimental Treatment2 Interventions
Each participant will receive a single oral dose of elinzanetant or placebo.
Group II: Elinzanetant single dose step 4Experimental Treatment2 Interventions
Each participant will receive a single oral dose of elinzanetant or placebo.
Group III: Elinzanetant single dose step 3Experimental Treatment2 Interventions
Each participant will receive a single oral dose of elinzanetant or placebo.
Group IV: Elinzanetant single dose step 2Experimental Treatment2 Interventions
Each participant will receive a single oral dose of elinzanetant or placebo.
Group V: Elinzanetant single dose step 1Experimental Treatment2 Interventions
Each participant will receive a single oral dose of elinzanetant or placebo.
Group VI: Elinzanetant multiple dose step 5Experimental Treatment2 Interventions
Each participant will receive multiple doses of elinzanetant or placebo administered once a day for 7 consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Elinzanetant (BAY3427080)
2022
Completed Phase 3
~1940

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BayerLead Sponsor
2,287 Previous Clinical Trials
25,558,697 Total Patients Enrolled
~14 spots leftby Feb 2026