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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
14
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.
PRAHealthSciences
Groningen, Netherlands
Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of elinzanetant without concomitant administration of esomeprazole.
(AUC(0-tlast) will be used as main parameter if AUC cannot be calculated.)
Time frame: Period 1: Predose, Day 1 to Day 8.
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of elinzanetant without concomitant administration of esomeprazole.
Time frame: Period 1: Predose, Day 1 to Day 8.
Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of elinzanetant with concomitant administration of esomeprazole.
(AUC(0-tlast) will be used as main parameter if AUC cannot be calculated.)
Time frame: Period 2: Predose, Day 1 to Day 8.
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of elinzanetant with concomitant administration of esomeprazole.
Time frame: Period 2: Predose, Day 1 to Day 8.
Number of participants with treatment-emergent adverse events (TEAEs).
Time frame: After first application of intervention up to 21 days after last dosing.
Absolute bioavailability (F) of Elinzanetant.
Time frame: Period 1 : Predose, Day 1 to Day 8.
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