Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenPhase 1NCT04981431
A Study to Learn How Safe Elinzanetant is, How it Affects the Body, and How it Moves Into, Through and Out of the Body After Single and Multiple Doses in Japanese Healthy Female Adults
A Phase 1 study testing Elinzanetant (BAY3427080) in people with Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, run by Bayer at 1 site in Japan.
Trial summary
Researchers are looking for a new way to treat women who have symptoms that are caused by the sex hormonal changes that happen when a woman's body is going through the menopause. These symptoms include Vasomotor Symptoms (VMS) (hot flashes), and changes in blood pressure. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
- What is being tested?
- Elinzanetant (BAY3427080)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteJapan
- Study dates
- 11 Aug 2021to 13 Mar 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Japanese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, blood pressure, pulse rate, 12 lead electrocardiogram (ECG), body temperature, and laboratory tests.
- Non-smoker, at least from 3 months before the screening visit onwards.
- Body weight of at least 40 kg and body mass index (BMI) within the range 18.0 and 30.0 kg/m^2 (inclusive).
Who cannot join
- Pregnant or breastfeeding women.
- Any clinically relevant abnormal findings in medical history and physical examination.
- 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.
- Relevant diseases or febrile illness within the last 4 weeks prior to the first study intervention administration.
- Regular use of medicines, or dietary supplements or other substances, e.g., carnitine products, anabolics, high dose vitamins.
- Use of any systemic or topical medicine or substance within 4 weeks before first study drug intervention, which oppose the study objectives, or which might influence them. This includes medicines and natural remedies (e.g St. John's wort) that are altering the activity of CYP3A4 enzyme and the transporters Breast Cancer Resistance Protein (BCRP) and P-gp.
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- ECG: PR interval > 210 msec, QT interval corrected using Bazett's formula (QTcB) >450 msec, QRS duration > 110 msec at screening visit.
- Systolic blood pressure below 90 or above 140 mmHg; diastolic blood pressure below 40 or above 90 mmHg at screening visit.
- Pulse rate below 50 or above 90 beats per minute (bpm; a lower pulse rate between 45 and 50 bpm is acceptable in case of normal thyroid function and absence of symptoms of bradycardia) at screening visit.
- Participants with a presence of any of the following, confirmed by a repeat test: aspartate aminotransferase (AST), alanine aminotransferase (ALT) and/or bilirubin above 1.2 x upper limit of normal (ULN) at screening visit.
- Participants with a presence of gamma-glutamyl transferase (GGT) > ULN confirmed by a repeat test, CK (creatine kinase)>2x ULN, and thyroid-stimulating hormone (TSH) outside normal range at screening visit.
- History of COVID-19 (coronavirus disease 2019).
- Suspected or confirmed active or prior SARS-CoV-2 (severe acute respiratory syndrome coronavirus type 2) infection according to local guidelines/practice.
- Contact with SARS-CoV-2- positive or COVID-19 patient within the last 4 weeks prior to admission to the study site.
- Positive SARS-CoV-2 viral RNA (ribonucleic acid) test.
- Vaccination against SARS-CoV-2 within 14 days before first administration of the study intervention or vaccination planned before completion of the last study visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled, Single-blind, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics After Single and Multiple Dose of Elinzanetant in Japanese Healthy Female Adult Participants
Researchers are looking for a new way to treat women who have symptoms that are caused by the sex hormonal changes that happen when a woman's body is going through the menopause. These symptoms include Vasomotor Symptoms (VMS) (hot flashes), and changes in blood pressure. Menopause is when women stop having a menstrual cycle, also called a period. During the period, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life.
In this study, researchers want to learn more about a new substance called elinzanetant. Elinzanetant was developed to treat symptoms caused by sex hormonal changes. It works by blocking a group of proteins called neurokinins from sending signals to other parts of the body, which play a role in starting the symptoms.
Read more
In this study, the researchers will learn how safe elinzanetant is and how it affects the body of healthy Japanese women compared to a placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Before a new treatment can be given to patients, researchers do studies in healthy participants to learn more about its safety and how it acts in the body.
There will be 2 parts to this study. In Part A, the participants will take a single dose of either elinzanetant or the placebo. In Part B, the participants will take multiple doses of elinzanetant or the placebo. The participants will take each study treatment as capsules by mouth.
The main purpose of this study is to learn how safe elinzanetant is and how it affects the body. To answer this question, the researchers will collect the medical problems the participants have after receiving the treatment and that may or may not be related to the study treatment. These medical problems are also known as "adverse events".
During Part A, the participants will stay at their study site for a total of 9 days. They will take either elinzanetant or the placebo only on Day 1 of their stay. During Part B, the participants will stay at their study site for a total of 15 days. They will take either elinzanetant or the placebo once a day for 7 days of their stay. Each participant will be in the study for a total of approximately 5 weeks for Part A and approximately 6 weeks for Part B.
During the study, the doctors will:
- take blood and urine samples;
- check the participants' health;
- ask the participants questions about what medicines they are taking and if they are having adverse events.
- Being tested
- Elinzanetant (BAY3427080), Placebo
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elinzanetant (BAY3427080)Drug
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Elinzanetant single dose step 1 | Experimental | Each participant will receive a single oral dose of elinzanetant or placebo. Receives: Drug: Elinzanetant (BAY3427080); Drug: Placebo |
| Elinzanetant single dose step 2 | Experimental | Each participant will receive a single oral dose of elinzanetant or placebo. Receives: Drug: Elinzanetant (BAY3427080); Drug: Placebo |
| Elinzanetant single dose step 3 | Experimental | Each participant will receive a single oral dose of elinzanetant or placebo. Receives: Drug: Elinzanetant (BAY3427080); Drug: Placebo |
| Elinzanetant single dose step 4 | Experimental | Each participant will receive a single oral dose of elinzanetant or placebo. Receives: Drug: Elinzanetant (BAY3427080); Drug: Placebo |
| Elinzanetant single dose step 6 | Experimental | Each participant will receive a single oral dose of elinzanetant or placebo. Receives: Drug: Elinzanetant (BAY3427080); Drug: Placebo |
| Elinzanetant multiple dose step 5 | Experimental | Each participant will receive multiple doses of elinzanetant or placebo administered once a day for 7 consecutive days. Receives: Drug: Elinzanetant (BAY3427080); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with and severity of treatment-emergent adverse events (TEAEs)
Measured: Up to 2 weeks after start of dosing
Secondary outcomes (8)
Cmax (maximum observed drug concentration after single dose administration) of elinzanetant
Only for single dose steps 1 to 4 and 6
Measured: Day 1 pre-dose until 144 hours post-dose
Cmax/D (Cmax divided by dose) of elinzanetant
Only for single dose steps 1 to 4 and 6
Measured: Day 1 pre-dose until 144 hours post-dose
AUC (area under the concentration vs. time curve from zero to infinity after single dose) of elinzanetant
Only for single dose steps 1 to 4 and 6
Measured: Day 1 pre-dose until 144 hours post-dose
AUC/D (AUC divided by dose) of elinzanetant
Only for single dose steps 1 to 4 and 6
Measured: Day 1 pre-dose until 144 hours post-dose
Cmax,md (maximum observed drug concentration after multiple dose administration) of elinzanetant
Only for multiple dose step 5
Measured: Day 7 (pre-dose until 144 hours post-dose)
Cmax,md/D (Cmax,md divided by dose) of elinzanetant
Only for multiple dose step 5
Measured: Day 7 (pre-dose until 144 hours post-dose)
AUC(0-24)md (AUC from time 0 to 24 h after multiple dose) of elinzanetant
Only for multiple dose step 5
Measured: Day 7 (pre-dose until 24 hours post-dose)
AUC(0-24)md/D (AUC(0-24)md divided by dose) of elinzanetant
Only for multiple dose step 5
Measured: Day 7 (pre-dose until 24 hours post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start11 Aug 2021
- Primary completion13 Mar 2022
- Study completion13 Mar 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
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981431
- Sponsor's protocol ID
- 21774
- Status last verified
- Mar 2022
- First submitted
- 5 Jul 2021
- Last updated
- 29 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 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Single-blind, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics After Single and Multiple Dose of Elinzanetant in Japanese Healthy Female Adult Participants
- ClinicalTrials.gov ID
- NCT04981431
- Acronym / sponsor ID
- 21774
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 13 Mar 2022 (actual)
- Study completion
- 13 Mar 2022 (actual)
- First posted
- 29 Jul 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 new way to treat women who have symptoms that are caused by the sex hormonal changes that happen when a woman's body is going through the menopause. These symptoms include Vasomotor Symptoms (VMS) (hot flashes), and changes in blood pressure. Menopause is when women stop having a menstrual cycle, also called a period. During the period, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life.
In this study, researchers want to learn more about a new substance called elinzanetant. Elinzanetant was developed to treat symptoms caused by sex hormonal changes. It works by blocking a group of proteins called neurokinins from sending signals to other parts of the body, which play a role in starting the symptoms.
In this study, the researchers will learn how safe elinzanetant is and how it affects the body of healthy Japanese women compared to a placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Before a new treatment can be given to patients, researchers do studies in healthy participants to learn more about its safety and how it acts in the body.
There will be 2 parts to this study. In Part A, the participants will take a single dose of either elinzanetant or the placebo. In Part B, the participants will take multiple doses of elinzanetant or the placebo. The participants will take each study treatment as capsules by mouth.
The main purpose of this study is to learn how safe elinzanetant is and how it affects the body. To answer this question, the researchers will collect the medical problems the participants have after receiving the treatment and that may or may not be related to the study treatment. These medical problems are also known as "adverse events".
During Part A, the participants will stay at their study site for a total of 9 days. They will take either elinzanetant or the placebo only on Day 1 of their stay. During Part B, the participants will stay at their study site for a total of 15 days. They will take either elinzanetant or the placebo once a day for 7 days of their stay. Each participant will be in the study for a total of approximately 5 weeks for Part A and approximately 6 weeks for Part B.
During the study, the doctors will:
- take blood and urine samples;
- check the participants' health;
- ask the participants questions about what medicines they are taking and if they are having adverse events.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Elinzanetant single dose step 1 | Experimental | Drug: Elinzanetant (BAY3427080), Drug: PlaceboEach participant will receive a single oral dose of elinzanetant or placebo. |
| Elinzanetant single dose step 2 | Experimental | Drug: Elinzanetant (BAY3427080), Drug: PlaceboEach participant will receive a single oral dose of elinzanetant or placebo. |
| Elinzanetant single dose step 3 | Experimental | Drug: Elinzanetant (BAY3427080), Drug: PlaceboEach participant will receive a single oral dose of elinzanetant or placebo. |
| Elinzanetant single dose step 4 | Experimental | Drug: Elinzanetant (BAY3427080), Drug: PlaceboEach participant will receive a single oral dose of elinzanetant or placebo. |
| Elinzanetant single dose step 6 | Experimental | Drug: Elinzanetant (BAY3427080), Drug: PlaceboEach participant will receive a single oral dose of elinzanetant or placebo. |
| Elinzanetant multiple dose step 5 | Experimental | Drug: Elinzanetant (BAY3427080), Drug: PlaceboEach participant will receive multiple doses of elinzanetant or placebo administered once a day for 7 consecutive days. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Japanese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, blood pressure, pulse rate, 12 lead electrocardiogram (ECG), body temperature, and laboratory tests.
- Non-smoker, at least from 3 months before the screening visit onwards.
- Body weight of at least 40 kg and body mass index (BMI) within the range 18.0 and 30.0 kg/m^2 (inclusive).
Key exclusion criteria (16 listed)
- Pregnant or breastfeeding women.
- Any clinically relevant abnormal findings in medical history and physical examination.
- 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.
- Relevant diseases or febrile illness within the last 4 weeks prior to the first study intervention administration.
- Regular use of medicines, or dietary supplements or other substances, e.g., carnitine products, anabolics, high dose vitamins.
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)Oral administration | Drug | Elinzanetant multiple dose step 5, Elinzanetant single dose step 1, Elinzanetant single dose step 2, Elinzanetant single dose step 3, Elinzanetant single dose step 4, Elinzanetant single dose step 6 |
| PlaceboOral administration | Drug | Elinzanetant multiple dose step 5, Elinzanetant single dose step 1, Elinzanetant single dose step 2, Elinzanetant single dose step 3, Elinzanetant single dose step 4, Elinzanetant single dose step 6 |
Primary outcome
Number of participants with and severity of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 weeks after start of dosing
8 secondary outcomes
Cmax (maximum observed drug concentration after single dose administration) of elinzanetant
Time frame: Day 1 pre-dose until 144 hours post-dose
Cmax/D (Cmax divided by dose) of elinzanetant
Time frame: Day 1 pre-dose until 144 hours post-dose
AUC (area under the concentration vs. time curve from zero to infinity after single dose) of elinzanetant
Time frame: Day 1 pre-dose until 144 hours post-dose
AUC/D (AUC divided by dose) of elinzanetant
Time frame: Day 1 pre-dose until 144 hours post-dose
Cmax,md (maximum observed drug concentration after multiple dose administration) of elinzanetant
Time frame: Day 7 (pre-dose until 144 hours post-dose)
Cmax,md/D (Cmax,md divided by dose) of elinzanetant
Time frame: Day 7 (pre-dose until 144 hours post-dose)
AUC(0-24)md (AUC from time 0 to 24 h after multiple dose) of elinzanetant
Time frame: Day 7 (pre-dose until 24 hours post-dose)
AUC(0-24)md/D (AUC(0-24)md divided by dose) of elinzanetant
Time frame: Day 7 (pre-dose until 24 hours post-dose)
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 29 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) in people with Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, run by Bayer at 1 site in Japan.
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 3 inclusion and 16 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 29 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 Japan. 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?
Number of participants with and severity of treatment-emergent adverse events (TEAEs) (time frame: Up to 2 weeks after start of dosing). 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 29 Mar 2022; AzTrials last refreshed its copy on 26 Oct 2026.