A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults
Condition: Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men; Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers are looking for a better way to treat people who have vasomotor symptoms (VMS).
      VMS such as hot flashes are caused by hormonal changes occurring during menopausal transition
      when women may have also changes in their monthly cycles.

      The study treatment, elinzanetant (BAY3427080), was developed to work by blocking neurokinin
      receptors from working. These receptors can cause changes in the body which can affect
      hormone levels in men and women.

      Acid is created by the stomach to help break down and digest food. A type of treatment for
      overly production of acid by the stomach are called proton pump inhibitors which are
      currently available for people who have stomach and digestion problems. Proton pump
      inhibitors work by lowering the amount of acid created by the stomach. In this study, the
      researchers want to learn about elinzanetant oral bioavailability when taken with a proton
      pump inhibitor called esomeprazole. They want to learn if taking these drugs together affects
      the oral bioavailability.

      The researchers will study how esomeprazole affects the way elinzanetant moves into, through,
      and out of the body. To do this, the doctors and their team will take blood samples from the
      participants. These samples will be used to measure the levels of elinzanetant in the
      participants' blood when it is taken with and without esomeprazole.

      This study will include healthy adult participants.

      There will be 2 periods in this study. It is planned that all of the participants will take
      part in both periods. During Period 1, the participants will take elinzanetant 1 time as a
      capsule by mouth. The participants will also receive a very small amount of radioactive
      elinzanetant, also called a microtracer, given through needle in a vein. During Period 2, the
      participants will take esomeprazole once a day for 5 days as tablets by mouth. On the last
      day, the participants will also take elinzanetant 1 time as a capsule by mouth.

      During this study, the participants will visit the study site 3 times. The participants will
      stay at the study site for 9 days in Period 1 and for 12 days in Period 2. Each participant
      will be in the study for up to 9 weeks.

      During the study, the doctors will take urine samples. They will also ask the participants
      about any medications they have been taking, 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); Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Elinzanetant given orally as single dose capsule and intravenous as single dose in Period 1. Elinzanetant given orally as single dose capsule in Period 2.; Esomeprazole given orally once daily for 5 days in Period 2.
Other intervention name(s): NT-814
Intervention MeSH terms: Esomeprazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hot flushes; Vasomotor symptoms; Elinzanetant; Drug-drug interaction; Proton pump inhibitor; Pharmcokinetics