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
Condition: Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
Study type: Interventional
Phase: Phase 1

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.
    


Intervention name(s): Elinzanetant (BAY3427080); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Oral administration
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Other