Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenPhase 1NCT05061563
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
A Phase 1 study testing Elinzanetant (BAY3427080) and Esomeprazole in people with Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men and Hot Flashes, run by Bayer at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes
- What is being tested?
- Elinzanetant (BAY3427080) and Esomeprazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Sep 2021to 23 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Male participants: Male participants of reproductive potential must agree to use a condom (with or without spermicide) when sexually active. This applies for the time period between the signing of the informed consent form (ICF) until 5 days after the last dose of study intervention. Female partners of childbearing potential of male participants do not need to follow special precautions.
- Female participants: Women of childbearing potential will have to use highly effective non-hormonal contraception when having sexual intercourse with a male partner from signing the ICF until 5 days after last dose of the study drug.
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- Women of non-childbearing potential are not required to use contraception. Non-childbearing potential is defined as
- 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.
Who cannot join
- Any clinically relevant abnormal findings in medical history and physical examination which in the opinion of the investigators, may put the participant at risk because of his/her participation in the trial or provide difficulties in interpreting the trial data.
- History or evidence of any clinically relevant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other clinically relevant disease, as judged by the investigator.
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal.
- Any medical disorder, condition or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator.
- Known hypersensitivity to the study interventions (active substances, or excipients of the preparations).
- Known severe allergies e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids, urticaria or significant non-allergic drug reactions.
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- Relevant diseases within the last 4 weeks prior to the first study intervention administration.
- Febrile illness within 4 weeks before first study intervention administration.
- Contraindications for the use of esomeprazole, especially known hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
- Use of drugs which may affect absorption (e.g. loperamide, metoclopramide) within 1 week before first study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Non-randomized,Fixed-sequence Crossover Study to Investigate the Effects of a Proton Pump Inhibitor on the Pharmacokinetics of Elinzanetant (BAY 3427080) as Well as Assessment of the Absolute Bioavailability of Elinzanetant Using a Single Intravenous Microtracer Dose of [13C5]BAY 3427080 in Male and Female Healthy Participants
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.
Read more
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.
- Being tested
- Elinzanetant (BAY3427080), Esomeprazole
- Keywords
- Hot flushes, Vasomotor symptoms, Elinzanetant, Drug-drug interaction, Proton pump inhibitor, Pharmcokinetics
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elinzanetant (BAY3427080)Drug
Also called NT-814
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.
EsomeprazoleDrug
Esomeprazole given orally once daily for 5 days in Period 2.
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Experimental | A single dose of elinzanetant and an additional IV (microtracer dose) of [13C5]BAY 3427080 will be administered. Receives: Drug: Elinzanetant (BAY3427080) |
| Period 2 | Experimental | Once daily oral dose of esomeprazole and a single oral dose of elinzanetant will be administered. Receives: Drug: Elinzanetant (BAY3427080); Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.
Measured: 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.)
Measured: 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.
Measured: Period 2: Predose, Day 1 to Day 8.
Secondary outcomes (2)
Number of participants with treatment-emergent adverse events (TEAEs).
Measured: After first application of intervention up to 21 days after last dosing.
Absolute bioavailability (F) of Elinzanetant.
Measured: Period 1 : Predose, Day 1 to Day 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start30 Sep 2021
- Primary completion9 Dec 2021
- Study completion23 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061563
- Sponsor's protocol ID
- 21772
- Other IDs
- 2021-002032-24
- Status last verified
- Mar 2022
- First submitted
- 20 Sep 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-randomized,Fixed-sequence Crossover Study to Investigate the Effects of a Proton Pump Inhibitor on the Pharmacokinetics of Elinzanetant (BAY 3427080) as Well as Assessment of the Absolute Bioavailability of Elinzanetant Using a Single Intravenous Microtracer Dose of [13C5]BAY 3427080 in Male and Female Healthy Participants
- ClinicalTrials.gov ID
- NCT05061563
- Acronym / sponsor ID
- 21772
- Keywords
- Hot flushes, Vasomotor symptoms, Elinzanetant, Drug-drug interaction, Proton pump inhibitor, Pharmcokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Experimental | Drug: Elinzanetant (BAY3427080)A single dose of elinzanetant and an additional IV (microtracer dose) of [13C5]BAY 3427080 will be administered. |
| Period 2 | Experimental | Drug: Elinzanetant (BAY3427080), Drug: EsomeprazoleOnce daily oral dose of esomeprazole and a single oral dose of elinzanetant will be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- Any clinically relevant abnormal findings in medical history and physical examination which in the opinion of the investigators, may put the participant at risk because of his/her participation in the trial or provide difficulties in interpreting the trial data.
- History or evidence of any clinically relevant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other clinically relevant disease, as judged by the investigator.
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal.
- Any medical disorder, condition or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator.
- Known hypersensitivity to the study interventions (active substances, or excipients of the preparations).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elinzanetant (BAY3427080)Also: NT-814Elinzanetant given orally as single dose capsule and intravenous as single dose in Period 1. Elinzanetant given orally as single dose capsule in Period 2. | Drug | Period 1, Period 2 |
| EsomeprazoleEsomeprazole given orally once daily for 5 days in Period 2. | Drug | Period 2 |
Primary outcome
Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of elinzanetant without concomitant administration of esomeprazole.
Time frame: Period 1: Predose, Day 1 to Day 8.
(AUC(0-tlast) will be used as main parameter if AUC cannot be calculated.)
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.
Time frame: Period 2: Predose, Day 1 to Day 8.
(AUC(0-tlast) will be used as main parameter if AUC cannot be calculated.)
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.
2 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elinzanetant (BAY3427080) and Esomeprazole in people with Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men and Hot Flashes, run by Bayer at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of elinzanetant without concomitant administration of esomeprazole. (time frame: Period 1: Predose, Day 1 to Day 8.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.