A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work Normally
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 better way to treat people who have vasomotor symptoms (VMS).

      The symptoms of VMS are hot flashes. These symptoms can be caused by changes in sex hormone
      levels. An example of a change in sex hormone levels is when a woman reaches the time in
      their life where they no longer have their period. Hormones are substances in the blood that
      help body organs to work in specific ways. Women who no longer have their period may have a
      protein called neurokinin sending more signals than usual to other parts of the body.
      Researchers think that this may play a role in causing VMS.

      In this study, the researchers want to learn more about a new substance called elinzanetant.
      Researchers think elinzanetant may help people with VMS. It works by blocking neurokinin from
      sending signals to other parts of the body. There are treatments available for VMS, but these
      do not work for all people and may cause medical problems for some people.

      The main purpose of this study is to help the researchers learn more about how elinzanetant
      moves into, through and out of the body in participants with kidneys that do not work as well
      as they should compared to healthy participants whose kidneys work normally. To do this, the
      doctors will take blood samples from the participants at different times during the study and
      measure the levels of elinzanetant in the blood. This will help the researchers learn more
      about whether elinzanetant could be given to treat VMS in people who also have kidneys that
      do not work as well as they should.

      This study will include adult participants who have kidneys that do not work as well as they
      should and participants whose kidneys work normally. The participants who have kidneys that
      do not work as well as they should will be split into 2 groups based on how severe their
      kidney problems are. All of the participants will take elinzanetant once as a tablet by
      mouth.

      The participants will be in the study for about 1 month and will stay at their study site for
      7 days in a row. During this visit, the participants will:

        -  have their overall health checked

        -  have scans of their heart taken using an electrocardiogram

        -  have blood and urine samples taken

        -  answer questions about how they are feeling, what medications they are taking, and what
           adverse events they are having

      The doctors will keep track of any adverse events. An adverse event is any medical problem
      that a participant has during a study. Doctors keep track of all adverse events that happen
      in studies, even if they do not think the adverse events might be related to the study
      treatments.
    


Intervention name(s): Elinzanetant (BAY3427080)
Intervention type(s): Drug
Intervention description(s): Single oral dose of elinzanetant on Day 1.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hot flushes; Elinzanetant; Investigation of pharmacokinetics and safety in renal impaired participants