Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenPhase 1NCT05028608
A Study to Learn What Happens to Elinzanetant in the Body When Taken With or Without Carbamazepine, and How Safe it is in Healthy Men and Women Aged 18 to 60 Years.
A Phase 1 study testing Elinzanetant (BAY3427080), Midazolam and Carbamazepine in people with Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, run by Bayer at 1 site in Germany.
Trial summary
Researchers are looking for a better way to treat people who have symptoms caused by hormonal changes, such as hot flashes. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to the treatment in the body. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy 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), Midazolam and Carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 6 Sep 2021to 20 Jan 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 60 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 electrocardiogram (ECG), vital signs, respiratory rate and body temperature.
- Body weight above or equal 50 kg and body mass index (BMI) within the range 18.0 and 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. Women of non-childbearing potential are not required to use contraception.
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.
- Known hypersensitivity to the study interventions (active substances, or excipients of the preparations), or structurally related drugs to CBZ (carbamazepine, e.g. tricyclic antidepressants).
- History of bone marrow depression.
- History of clinically hepatic disorders including hepatic porphyria (e.g. acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda).
- History or family history of severe cutaneous reactions including toxic epidermal necrolysis and Stevens-Johnson syndrome.
- Human leukocyte antigen A (HLA-A) *31:01 or human leukocyte antigen B (HLA-B) *15:02 allele.
Show all 10Show fewer
- History of myotonic dystrophy.
- History of clinically relevant psychiatric disorder, including psychosis or latent psychosis.
- History of epileptic seizures.
- History of clinically relevant depression, or suicidal ideation or behavior.
Trial locations and contacts
1 site in 1 country.
Germany1 site
CRS Clinical-Research-Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, 68167
About this study
Official title: Open-label, Fixed Sequence Crossover Study to Investigate the Effects of Carbamazepine on the Pharmacokinetics of Elinzanetant (BAY 3427080) in Healthy Participants.
Researchers are looking for a better way to treat people who have symptoms caused by hormonal changes, such as hot flashes. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to the treatment in the body.
In this study researchers want to learn more about a new substance called elinzanetant.
Read more
Elinzanetant, the study treatment, was developed to treat symptoms caused by hormonal changes, such as hot flashes. Carbamazepine is a drug that is already available for doctors to prescribe, for example against seizures. Midazolam is a treatment that is already available for doctors to prescribe as a sedative (calming treatment) or to help people sleep.
In this study, the researchers will learn how much elinzanetant gets into the participants' blood when taken with or without carbamazepine. They will also get to know if taking elinzanetant will affect the amount of midazolam in the blood.
The participants will all take elinzanetant as capsules, carbamazepine as tablets and midazolam as a liquid by mouth. On some days, they will take only 1 treatment of midazolam or carbamazepine or only elinzanetant. On other days, they will take two study treatments. On 3 different days during the study, the participants will take elinzanetant with midazolam, elinzanetant with carbamazepine and midazolam with carbamazepine.
Each participant will be in the study for up to 10 weeks. But, the entire study will last about 4 months.
During the study, all of the participants will stay at the study site for 2 periods, period 1 with 9 overnight stays and period 2 with 22 overnight stays at the study site. In addition, there will be two ambulatory visits, one before joining the study and one at the end of the study.
Blood and urine samples will be collected. The doctors will also check the participants' heart health using an electrocardiogram (ECG). The participants will answer questions about how they are feeling and about any medications they are taking.
- Being tested
- Elinzanetant (BAY3427080), Midazolam, Carbamazepine
- Keywords
- Vasomotor symptoms,, Menopause,, Healthy volunteers.
- 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
Also called NT-814
Elinzanetant given orally as a single dose in Period 1 and in Period 2.
MidazolamDrug
Midazolam given orally as single dose in Period 1 and in Period 2.
CarbamazepineDrug
Carbamazepine given orally twice daily in Period 2 .
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Experimental | Fixed treatment sequence starting with 2 single oral doses of midazolam and a single dose of elinzanetant. Receives: Drug: Elinzanetant (BAY3427080); Drug: Midazolam |
| Period 2 | Experimental | Up titration of carbamazepine over 4 days (dose 1, 2, 3) continued by fixed dose 3 of carbamazepine prior to administration of midazolam / elinzanetant, followed by carbamazepine administration. Receives: Drug: Elinzanetant (BAY3427080); Drug: Midazolam; Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of elinzanetant with carbamazepine.
AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose.
Measured: Period 2: Predose, Day 1 to Day 8
AUC of elinzanetant without carbamazepine.
AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose.
Measured: Period 1: Predose, Day 1 to Day 8
Cmax of elinzanetant with carbamazepine.
Cmax: Maximum observed drug concentration in measured matrix after single dose administration.
Measured: Period 2: Predose, Day 1 to Day 8
Cmax of elinzanetant without carbamazepine.
Cmax: Maximum observed drug concentration in measured matrix after single dose administration.
Measured: Period 1: Predose, Day 1 to Day 8
Secondary outcomes (2)
Number of participants with treatment-emergent adverse events (TEAEs) without concomitant carbamazepine.
Measured: After the first administration of study intervention up to 7 days after the last administration
Number of participants with TEAEs with concomitant carbamazepine.
Measured: After the first administration of study intervention up to 7 days after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start6 Sep 2021
- Primary completion31 Oct 2021
- Study completion20 Jan 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
- 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
- NCT05028608
- Sponsor's protocol ID
- 21667
- Other IDs
- 2021-000309-26
- Status last verified
- Feb 2022
- First submitted
- 26 Aug 2021
- Last updated
- 25 Feb 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 later will 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 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Fixed Sequence Crossover Study to Investigate the Effects of Carbamazepine on the Pharmacokinetics of Elinzanetant (BAY 3427080) in Healthy Participants.
- ClinicalTrials.gov ID
- NCT05028608
- Acronym / sponsor ID
- 21667
- Keywords
- Vasomotor symptoms,, Menopause,, Healthy volunteers.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 31 Aug 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 symptoms caused by hormonal changes, such as hot flashes. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to the treatment in the body.
In this study researchers want to learn more about a new substance called elinzanetant.
Elinzanetant, the study treatment, was developed to treat symptoms caused by hormonal changes, such as hot flashes. Carbamazepine is a drug that is already available for doctors to prescribe, for example against seizures. Midazolam is a treatment that is already available for doctors to prescribe as a sedative (calming treatment) or to help people sleep.
In this study, the researchers will learn how much elinzanetant gets into the participants' blood when taken with or without carbamazepine. They will also get to know if taking elinzanetant will affect the amount of midazolam in the blood.
The participants will all take elinzanetant as capsules, carbamazepine as tablets and midazolam as a liquid by mouth. On some days, they will take only 1 treatment of midazolam or carbamazepine or only elinzanetant. On other days, they will take two study treatments. On 3 different days during the study, the participants will take elinzanetant with midazolam, elinzanetant with carbamazepine and midazolam with carbamazepine.
Each participant will be in the study for up to 10 weeks. But, the entire study will last about 4 months.
During the study, all of the participants will stay at the study site for 2 periods, period 1 with 9 overnight stays and period 2 with 22 overnight stays at the study site. In addition, there will be two ambulatory visits, one before joining the study and one at the end of the study.
Blood and urine samples will be collected. The doctors will also check the participants' heart health using an electrocardiogram (ECG). The participants will answer questions about how they are feeling and about any medications they are taking.
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), Drug: MidazolamFixed treatment sequence starting with 2 single oral doses of midazolam and a single dose of elinzanetant. |
| Period 2 | Experimental | Drug: Elinzanetant (BAY3427080), Drug: Midazolam, Drug: CarbamazepineUp titration of carbamazepine over 4 days (dose 1, 2, 3) continued by fixed dose 3 of carbamazepine prior to administration of midazolam / elinzanetant, followed by carbamazepine administration. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participant must be 18 to 60 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 electrocardiogram (ECG), vital signs, respiratory rate and body temperature.
- Body weight above or equal 50 kg and body mass index (BMI) within the range 18.0 and 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.
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.
- Known hypersensitivity to the study interventions (active substances, or excipients of the preparations), or structurally related drugs to CBZ (carbamazepine, e.g. tricyclic antidepressants).
- History of bone marrow depression.
- History of clinically hepatic disorders including hepatic porphyria (e.g. acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda).
- History or family history of severe cutaneous reactions including toxic epidermal necrolysis and Stevens-Johnson syndrome.
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 a single dose in Period 1 and in Period 2. | Drug | Period 1, Period 2 |
| MidazolamMidazolam given orally as single dose in Period 1 and in Period 2. | Drug | Period 1, Period 2 |
| CarbamazepineCarbamazepine given orally twice daily in Period 2 . | Drug | Period 2 |
Primary outcome
AUC of elinzanetant with carbamazepine.
Time frame: Period 2: Predose, Day 1 to Day 8
AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose.
AUC of elinzanetant without carbamazepine.
Time frame: Period 1: Predose, Day 1 to Day 8
AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose.
Cmax of elinzanetant with carbamazepine.
Time frame: Period 2: Predose, Day 1 to Day 8
Cmax: Maximum observed drug concentration in measured matrix after single dose administration.
Cmax of elinzanetant without carbamazepine.
Time frame: Period 1: Predose, Day 1 to Day 8
Cmax: Maximum observed drug concentration in measured matrix after single dose administration.
2 secondary outcomes
Number of participants with treatment-emergent adverse events (TEAEs) without concomitant carbamazepine.
Time frame: After the first administration of study intervention up to 7 days after the last administration
Number of participants with TEAEs with concomitant carbamazepine.
Time frame: After the first administration of study intervention up to 7 days after the last administration
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 25 Feb 2022.
- Individual participant dataSharing planned: No. Availability of this study's data later will 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), Midazolam and Carbamazepine in people with Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, run by Bayer at 1 site in Germany.
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 7 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 25 Feb 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 Germany. 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?
AUC of elinzanetant with carbamazepine. (time frame: Period 2: 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 25 Feb 2022.