Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenPhase 1NCT05381142
A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 Years
A Phase 1 study testing Elinzanetant (BAY3427080) 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 China.
Trial summary
Researchers are looking for a better way to treat men and women with vasomotor symptoms, a condition of having hot flashes caused by hormonal changes. In women, these hormonal changes happen in the time around their menopause, the last period (menstrual cycle) a woman has. 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, Hot Flashes, Healthy Volunteers
- What is being tested?
- Elinzanetant (BAY3427080)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2022to 11 Jul 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
- Participant must be 40 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, vital signs, laboratory tests and electrocardiogram (ECG).
- Race: Chinese in China mainland.
- Body weight of at least 40 kg and body mass index (BMI) within the range 18.0 and 30.0 kg/m^2 (inclusive) at screening.
- Female:
- Women of childbearing potential will have to use highly effective non-hormonal contraception when having sexual intercourse with a male partner from signing the informed consent form until 5 days after last dose of the study intervention.
- Women of non-childbearing potential are not required to use contraception.
- Capable of giving signed informed consent.
Who cannot join
- Any clinically relevant abnormal findings in medical history and physical examination at screening or Day -1 which in the opinion of the investigators, may put the participant at risk because of 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.
- Known hypersensitivity to the study interventions (active substances, or excipients of the preparations).
- Use of any systemic or topical medicine or substance which oppose the study objectives, or which might influence them within 4 weeks before first administration of study intervention. This includes but is not limited to CYP P450 inducers/inhibitors, OATP substrates or P-gp substrates with narrow therapeutic range (e.g. digoxin, dabigatran etc).
- Regular use of therapeutic drugs or supplements, e.g., carnitine products, anabolics, high dose vitamins.
- Use of herbal drugs or natural remedies, e.g. St. John's wort within 4 weeks before first study intervention administration.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou University of TCM
Guangzhou, Guangdong, 510405
About this study
Official title: A Randomized, Single-blind, Placebo-controlled Study to Investigate the Pharmacokinetics, Safety and Tolerability of Single and Multiple Doses of Elinzanetant in Chinese Healthy Female Participants 40 to 65 Years of Age
Researchers are looking for a better way to treat men and women with vasomotor symptoms, a condition of having hot flashes caused by hormonal changes.
In women, these hormonal changes happen in the time around their menopause, the last period (menstrual cycle) a woman has. After the menopause, the ovaries produce less and less sex hormones as a result of the natural ageing process and related hormonal adaptations. The decrease in hormones produced can lead to various symptoms that may be troublesome. Vasomotor symptoms are also seen in men.
Read more
The study treatment, elinzanetant, is under development to treat symptoms caused by hormonal changes. It works by blocking a substance called neurokinin, which is thought to play a role in starting hot flashes.
Previous studies have been done. This study will provide information on how to use elinzanetant in Chinese people.
The main purpose of this study is to learn how much of the study treatment elinzanetant gets into the participants' blood when a single dose is taken in healthy Chinese women.
To answer this question, the researchers will measure:
- The (average) total level of elinzanetant in the blood (also called AUC)
- The (average) highest level of elinzanetant in the blood (also called Cmax) The researchers also want to learn how much elinzanetant gets into the blood when taken for 6 days in a row.
Dependent on the treatment group, the participants will either take elinzanetant or placebo. First, a single dose of two capsules is taken by mouth and later multiple doses once a day for another 6 days in a row are taken.
Each participant will be in the study for approximately 22 days including 7 treatment days in total. Participants will stay in-house for 16 days. In addition, one visit to the study site prior start and four visits after the in-house period are planned.
During the study, the study team will:
- Do physical examinations
- Take blood and urine samples
- Check vital signs
- Examine the participants' heart health using electrocardiogram (ECG)
- Ask the participants questions about how they are feeling 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.
- Conditions
- Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes, Healthy Volunteers
- Being tested
- Elinzanetant (BAY3427080), Placebo
- 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 will be administered as a single dose on Study Day 1 and a multiple dose once daily for another 6 consecutive days on Study Day 8 to Study Day 13.
PlaceboDrug
Matching placebo will be administered the same as Elinzanetant (BAY3427080)
| Study group | Role | What they receive |
|---|---|---|
| Elinzanetant (BAY3427080) | Experimental | Healthy female participants who meet all of the inclusion criteria and do not meet any of the exclusion criteria will be randomized to treatment with elinzanetant. Receives: Drug: Elinzanetant (BAY3427080) |
| Placebo | Placebo comparator | Healthy female participants who meet all of the inclusion criteria and do not meet any of the exclusion criteria will be randomized and assigned to treatment with placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: maximum observed drug concentration in measured matrix after single dose administration
Measured: From pre-dose up to 168 hours after first dosing
AUC: area under the concentration vs. time curve from zero to infinity after single dose
AUC(0-tlast) will be used as the main parameter if AUC cannot be reliably determined
Measured: From pre-dose up to 168 hours after first dosing
Cmax,md: maximum observed drug concentration in measured matrix after multiple dose administration
Measured: From pre-dose up to 180 hours after last dosing
AUC(0-24)md: AUC from time 0 to 24 hours for multiple dosing
Measured: From pre-dose up to 180 hours after last dosing
Secondary outcomes (1)
Number of participants with and severity of treatment-emergent adverse events (TEAEs)
Measured: From first dose of study intervention until follow-up visit on day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start23 May 2022
- Primary completion11 Jul 2022
- Study completion11 Jul 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381142
- Sponsor's protocol ID
- 21756
- Status last verified
- Jul 2022
- First submitted
- 29 Apr 2022
- Last updated
- 27 Jul 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 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Placebo-controlled Study to Investigate the Pharmacokinetics, Safety and Tolerability of Single and Multiple Doses of Elinzanetant in Chinese Healthy Female Participants 40 to 65 Years of Age
- ClinicalTrials.gov ID
- NCT05381142
- Acronym / sponsor ID
- 21756
- Conditions
- Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 23 May 2022 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 19 May 2022 (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 men and women with vasomotor symptoms, a condition of having hot flashes caused by hormonal changes.
In women, these hormonal changes happen in the time around their menopause, the last period (menstrual cycle) a woman has. After the menopause, the ovaries produce less and less sex hormones as a result of the natural ageing process and related hormonal adaptations. The decrease in hormones produced can lead to various symptoms that may be troublesome. Vasomotor symptoms are also seen in men.
The study treatment, elinzanetant, is under development to treat symptoms caused by hormonal changes. It works by blocking a substance called neurokinin, which is thought to play a role in starting hot flashes.
Previous studies have been done. This study will provide information on how to use elinzanetant in Chinese people.
The main purpose of this study is to learn how much of the study treatment elinzanetant gets into the participants' blood when a single dose is taken in healthy Chinese women.
To answer this question, the researchers will measure:
- The (average) total level of elinzanetant in the blood (also called AUC)
- The (average) highest level of elinzanetant in the blood (also called Cmax) The researchers also want to learn how much elinzanetant gets into the blood when taken for 6 days in a row.
Dependent on the treatment group, the participants will either take elinzanetant or placebo. First, a single dose of two capsules is taken by mouth and later multiple doses once a day for another 6 days in a row are taken.
Each participant will be in the study for approximately 22 days including 7 treatment days in total. Participants will stay in-house for 16 days. In addition, one visit to the study site prior start and four visits after the in-house period are planned.
During the study, the study team will:
- Do physical examinations
- Take blood and urine samples
- Check vital signs
- Examine the participants' heart health using electrocardiogram (ECG)
- Ask the participants questions about how they are feeling 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elinzanetant (BAY3427080) | Experimental | Drug: Elinzanetant (BAY3427080)Healthy female participants who meet all of the inclusion criteria and do not meet any of the exclusion criteria will be randomized to treatment with elinzanetant. |
| Placebo | Placebo comparator | Drug: PlaceboHealthy female participants who meet all of the inclusion criteria and do not meet any of the exclusion criteria will be randomized and assigned to treatment with placebo. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant must be 40 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, vital signs, laboratory tests and electrocardiogram (ECG).
- Race: Chinese in China mainland.
- Body weight of at least 40 kg and body mass index (BMI) within the range 18.0 and 30.0 kg/m^2 (inclusive) at screening.
- Female:
Key exclusion criteria (6 listed)
- Any clinically relevant abnormal findings in medical history and physical examination at screening or Day -1 which in the opinion of the investigators, may put the participant at risk because of 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.
- Known hypersensitivity to the study interventions (active substances, or excipients of the preparations).
- Use of any systemic or topical medicine or substance which oppose the study objectives, or which might influence them within 4 weeks before first administration of study intervention. This includes but is not limited to CYP P450 inducers/inhibitors, OATP substrates or P-gp substrates with narrow therapeutic range (e.g. digoxin, dabigatran etc).
- Regular use of therapeutic drugs or supplements, 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)Also: NT-814Elinzanetant will be administered as a single dose on Study Day 1 and a multiple dose once daily for another 6 consecutive days on Study Day 8 to Study Day 13. | Drug | Elinzanetant (BAY3427080) |
| PlaceboMatching placebo will be administered the same as Elinzanetant (BAY3427080) | Drug | Placebo |
Primary outcome
Cmax: maximum observed drug concentration in measured matrix after single dose administration
Time frame: From pre-dose up to 168 hours after first dosing
AUC: area under the concentration vs. time curve from zero to infinity after single dose
Time frame: From pre-dose up to 168 hours after first dosing
AUC(0-tlast) will be used as the main parameter if AUC cannot be reliably determined
Cmax,md: maximum observed drug concentration in measured matrix after multiple dose administration
Time frame: From pre-dose up to 180 hours after last dosing
AUC(0-24)md: AUC from time 0 to 24 hours for multiple dosing
Time frame: From pre-dose up to 180 hours after last dosing
1 secondary outcome
Number of participants with and severity of treatment-emergent adverse events (TEAEs)
Time frame: From first dose of study intervention until follow-up visit on day 21
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 27 Jul 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 and Hot Flashes, run by Bayer at 1 site in China.
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 8 inclusion and 6 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 27 Jul 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 China. 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. Some participants in this study may receive a placebo. 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?
Cmax: maximum observed drug concentration in measured matrix after single dose administration (time frame: From pre-dose up to 168 hours after first dosing). 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 27 Jul 2022.