A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy Participants
Condition: Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men; Hot Flashes; Healthy Volunteers
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers are looking for a better way to treat vasomotor symptoms, a condition of having
      hot flashes. The condition is caused by hormonal changes and occurs primarily in women, but
      can also affect men.

      The study treatment, elinzanetant, is under development to treat symptoms caused by hormonal
      changes. It works by blocking a substance called neurokinin from sending signals to other
      parts of the body, which is thought to play a role in starting hot flashes.

      Participants of this study will be healthy and will have no benefit from administration of
      elinzanetant. This study, however, will provide information on how to use it in people with
      vasomotor symptoms.

      In previous studies, elinzanetant doses tested and resulting blood levels were close to the
      levels intended for treatment. However, in future use, it cannot always be ruled out that
      higher elinzanetant concentrations may occur in the blood if patients are taking certain
      other drugs at the same time, or take more than the recommended dose of the drug.

      The main purpose of this study is to learn how safe elinzanetant is when higher doses than
      normally used are given compared to placebo in healthy participants. A placebo is a treatment
      that looks like a medicine but does not have any medicine in it.

      To answer this, researchers will compare the number of participants who have medical problems
      after taking elinzanetant to those treated with placebo. Doctors keep track of all medical
      problems that happen in studies, even if they do not think they might be related to the study
      treatments.

      The study consists of two parts. In part 1, the participants will either take a single dose
      of elinzanetant or placebo by mouth dependent on the treatment group. Four different
      increasing doses of elinzanetant will be tested.

      Participants in dose group 1 and 4 will participate in part 2. About 8 days after treatment
      in part 1, the participants will receive a single dose of moxifloxacin and a single dose of
      placebo as tablet by mouth 5 days apart. Whether the participant starts with moxifloxacin or
      placebo is decided by chance. Moxifloxacin is used to make sure that certain changes in heart
      rhythm can be detected in the study.

      Each participant will be in the study for about 6 weeks including 1 treatment day (part 1) or
      for about 8 weeks including 3 treatment days (part 1 & 2). Participants of part 1 will stay
      in-house for 7 days. Participants of part 2 will stay in-house for another 9 days. The
      in-house phase starts two days before intake of the study treatment. In addition, one visit
      before and one visit after the in-house phase to the study site is planned.

      During the study, the study team will:

        -  Do physical examinations

        -  Check vital signs

        -  Take blood and urine samples

        -  Examine the participants' heart health using electrocardiogram (ECG)

        -  Ask the participants questions about their mood and about sleepiness.
    


Intervention name(s): Moxifloxacin; Elinzanetant (BAY3427080); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose of 400 mg moxifloxacin; Single oral dose of elinzanetant; Single oral dose of placebo
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science