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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002032-24 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | A single dose of elinzanetant and an additional IV (microtracer dose) of [13C5]BAY 3427080 will be administered. |
|
| Period 2 | Experimental | Once daily oral dose of esomeprazole and a single oral dose of elinzanetant will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elinzanetant (BAY3427080) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | 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. | 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.) | 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. | Period 2: Predose, Day 1 to Day 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs). | After first application of intervention up to 21 days after last dosing. | |
| Absolute bioavailability (F) of Elinzanetant. | Period 1 : Predose, Day 1 to Day 8. |
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Inclusion Criteria:
Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Body weight of at least 50 kg and body mass index (BMI) within the range of 18.0 to 30.0 kg/m^2 (inclusive).
Male and female Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Postmenopausal state confirmed by follicle stimulating hormone (FSH) level >33.4 U/L, or above reference range from the local laboratory, or
Surgically sterilized by bilateral tubal ligation, bilateral oophorectomy with or without hysterectomy, or hysterectomy documented by medical report verification.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRAHealthSciences | Groningen | 9728 NZ | Netherlands |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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|
| Esomeprazole | Drug | Esomeprazole given orally once daily for 5 days in Period 2. |
|
| ID | Term |
|---|---|
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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