A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female 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 men and women with vasomotor symptoms, a
      condition of having hot flashes caused by hormonal changes.

      The study drug, 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 elinzanetant in
      people with vasomotor symptoms.

      The main purpose of this study is to learn whether the study drug elinzanetant (BAY3427080)
      affects the way the substrate drug dabigatran moves into, through and out of the body.

      One way of removing substances such as drugs from the body are proteins which act as
      transporters. One such transporter is called P-gp. As a so-called substrate of P-gp,
      dabigatran is typically removed from the body by P-gp transporters.

      The activity of transporters can be increased by substances called inducers and decreased by
      substances called inhibitors. It has been found in laboratory experiments that the study drug
      elinzanetant is a weak inhibitor of the P-gp transporter. Inhibition of this transporter can
      lead to an increase in the amount of drugs such as dabigatran in the blood.

      This study is therefore needed to make recommendations on how elinzanetant can be used safely
      together with other drugs that are removed from the body by the P-gp transporter.

      To answer this, the researchers will compare

        -  the average highest level of dabigatran in the blood (also referred to as Cmax)

        -  the average total level of dabigatran in the blood (also referred to as AUC) when
           dabigatran is given alone and is given together with elinzanetant. All participants will
           take one dose of dabigatran by mouth in the first period of the study. And after 4 days,
           the participants will take one dose of elinzanetant by mouth and at 30 minutes later,
           one dose of dabigatran by mouth during the second period of the study. The total
           duration of individual study participation will be about 4.5 weeks including the
           screening period. Each participant will stay in the center for 9 days with 8 overnight
           stays.

      During the study, the study team will:

        -  take blood and urine samples

        -  do physical examinations

        -  check the participants' overall health

        -  examine heart health using ECG

        -  check vital signs

        -  ask the participants questions about how they are feeling and what adverse events they
           are having.

      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); Dabigatran etexilate
Intervention type(s): Drug; Drug
Intervention description(s): Capsule, oral, single dose; Capsule, oral, single dose
Other intervention name(s): Pradaxa
Intervention MeSH terms: Dabigatran
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science