Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenPhase 1NCT05471817
A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female Participants
A Phase 1 study testing Elinzanetant (BAY3427080) and Dabigatran etexilate 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 Germany.
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. The study drug, elinzanetant, is under development to treat symptoms caused by hormonal changes. 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, Healthy Volunteers
- What is being tested?
- Elinzanetant (BAY3427080) and Dabigatran etexilate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 5 Aug 2022to 14 Nov 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, blood pressure (BP), pulse rate, 12-lead electrocardiogram (ECG), and laboratory tests.
- Body weight of at least 50 kg and body mass index (BMI) above or equal 18.0 and below or equal 30.0 kg/m² at screening.
- Male or female
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study.
- Thyroid-stimulating hormone (TSH) outside normal range at screening.
- Any lesion or condition considered a significant risk factor for major bleeding.
- Known or suspected coagulopathies.
- Estimated glomerular filtration rate (eGFR according to Chronic Kidney Disease Epidemiology Collaboration; CKD-EPI) below 90 mL/min/1.73 m2 at screening.
- Any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, within 2 weeks or 5 half-lives (whichever longer) prior to the first study intervention administration.
- Suspicion of drug or alcohol abuse.
- Smoker (current, or within 6 months before screening).
Trial locations and contacts
1 site in 1 country.
Germany1 site
CRS Clinical Research Services Wuppertal GmbH
Wuppertal, North Rhine-Westphalia, 42113
About this study
Official title: Open-label, Fixed Sequence Crossover Study to Determine the Effects of a Single Dose of Elinzanetant (BAY 3427080) on the Pharmacokinetics of Dabigatran Etexilate in Healthy Participants
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.
The study drug, elinzanetant, is under development to treat symptoms caused by hormonal changes. It works by blocking a substance called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes.
Read more
Participants of this study will be healthy and will have no benefit from administration of elinzanetant. This study, however, will provide information on how to use elinzanetant in people with vasomotor symptoms.
The main purpose of this study is to learn whether the study drug elinzanetant (BAY3427080) affects the way the substrate drug dabigatran moves into, through and out of the body.
One way of removing substances such as drugs from the body are proteins which act as transporters. One such transporter is called P-gp. As a so-called substrate of P-gp, dabigatran is typically removed from the body by P-gp transporters.
The activity of transporters can be increased by substances called inducers and decreased by substances called inhibitors. It has been found in laboratory experiments that the study drug elinzanetant is a weak inhibitor of the P-gp transporter. Inhibition of this transporter can lead to an increase in the amount of drugs such as dabigatran in the blood.
This study is therefore needed to make recommendations on how elinzanetant can be used safely together with other drugs that are removed from the body by the P-gp transporter.
To answer this, the researchers will compare
- the average highest level of dabigatran in the blood (also referred to as Cmax)
- the average total level of dabigatran in the blood (also referred to as AUC) when dabigatran is given alone and is given together with elinzanetant. All participants will take one dose of dabigatran by mouth in the first period of the study. And after 4 days, the participants will take one dose of elinzanetant by mouth and at 30 minutes later, one dose of dabigatran by mouth during the second period of the study. The total duration of individual study participation will be about 4.5 weeks including the screening period. Each participant will stay in the center for 9 days with 8 overnight stays.
During the study, the study team will:
- take blood and urine samples
- do physical examinations
- check the participants' overall health
- examine heart health using ECG
- check vital signs
- 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), Dabigatran etexilate
- 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
Capsule, oral, single dose
Dabigatran etexilateDrug
Also called Pradaxa
Capsule, oral, single dose
| Study group | Role | What they receive |
|---|---|---|
| EZN - DBG | Experimental | Participants will receive a single oral dose of dabigatran (DBG) etexilate in fasted state in Period 1; followed by a single oral dose of elinzanetant (EZN) and DBG etexilate (30 min after EZN) in fasted state in Period 2. Receives: Drug: Elinzanetant (BAY3427080); Drug: Dabigatran etexilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of unconjugated and total dabigatran when given without or together with a single oral dose of elinzanetant
Cmax: maximum observed drug concentration in plasma after single dose
Measured: Pre-dose and up until 72 hours post-dose of DBG etexilate
AUC of unconjugated and total dabigatran when given without or together with a single oral dose of elinzanetant
AUC(0-tlast) will be the primary endpoint if AUC cannot be determined in all participants. AUC: area under the concentration vs. time curve from zero to infinity after single dose; AUC(0-tlast): area under the concentration vs. time curve from zero to last quantifiable concentration after single dose
Measured: Pre-dose and up until 72 hours post-dose of DBG etexilate
Secondary outcomes (2)
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: After first study intervention in Period 1 and up to 72.5 hours post-dose of elinzanetant in Period 2 (around 8 days)
Number of participants with treatment-emergent adverse events (TEAEs) categorized by severity
Measured: After first study intervention in Period 1 and up to 72.5 hours post-dose of elinzanetant in Period 2 (around 8 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start5 Aug 2022
- Primary completion20 Sep 2022
- Study completion14 Nov 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
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471817
- Sponsor's protocol ID
- 22081
- Other IDs
- 2022-500201-41-00
- Status last verified
- Nov 2022
- First submitted
- 21 Jul 2022
- Last updated
- 22 Nov 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.vivli.org 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 member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Fixed Sequence Crossover Study to Determine the Effects of a Single Dose of Elinzanetant (BAY 3427080) on the Pharmacokinetics of Dabigatran Etexilate in Healthy Participants
- ClinicalTrials.gov ID
- NCT05471817
- Acronym / sponsor ID
- 22081
- 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
- 20 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 25 Jul 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.
The study drug, elinzanetant, is under development to treat symptoms caused by hormonal changes. It works by blocking a substance called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes.
Participants of this study will be healthy and will have no benefit from administration of elinzanetant. This study, however, will provide information on how to use elinzanetant in people with vasomotor symptoms.
The main purpose of this study is to learn whether the study drug elinzanetant (BAY3427080) affects the way the substrate drug dabigatran moves into, through and out of the body.
One way of removing substances such as drugs from the body are proteins which act as transporters. One such transporter is called P-gp. As a so-called substrate of P-gp, dabigatran is typically removed from the body by P-gp transporters.
The activity of transporters can be increased by substances called inducers and decreased by substances called inhibitors. It has been found in laboratory experiments that the study drug elinzanetant is a weak inhibitor of the P-gp transporter. Inhibition of this transporter can lead to an increase in the amount of drugs such as dabigatran in the blood.
This study is therefore needed to make recommendations on how elinzanetant can be used safely together with other drugs that are removed from the body by the P-gp transporter.
To answer this, the researchers will compare
- the average highest level of dabigatran in the blood (also referred to as Cmax)
- the average total level of dabigatran in the blood (also referred to as AUC) when dabigatran is given alone and is given together with elinzanetant. All participants will take one dose of dabigatran by mouth in the first period of the study. And after 4 days, the participants will take one dose of elinzanetant by mouth and at 30 minutes later, one dose of dabigatran by mouth during the second period of the study. The total duration of individual study participation will be about 4.5 weeks including the screening period. Each participant will stay in the center for 9 days with 8 overnight stays.
During the study, the study team will:
- take blood and urine samples
- do physical examinations
- check the participants' overall health
- examine heart health using ECG
- check vital signs
- 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
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EZN - DBG | Experimental | Drug: Elinzanetant (BAY3427080), Drug: Dabigatran etexilateParticipants will receive a single oral dose of dabigatran (DBG) etexilate in fasted state in Period 1; followed by a single oral dose of elinzanetant (EZN) and DBG etexilate (30 min after EZN) in fasted state in Period 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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, blood pressure (BP), pulse rate, 12-lead electrocardiogram (ECG), and laboratory tests.
- Body weight of at least 50 kg and body mass index (BMI) above or equal 18.0 and below or equal 30.0 kg/m² at screening.
- Male or female
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Key exclusion criteria (8 listed)
- Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study.
- Thyroid-stimulating hormone (TSH) outside normal range at screening.
- Any lesion or condition considered a significant risk factor for major bleeding.
- Known or suspected coagulopathies.
- Estimated glomerular filtration rate (eGFR according to Chronic Kidney Disease Epidemiology Collaboration; CKD-EPI) below 90 mL/min/1.73 m2 at screening.
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)Capsule, oral, single dose | Drug | EZN - DBG |
| Dabigatran etexilateAlso: PradaxaCapsule, oral, single dose | Drug | EZN - DBG |
Primary outcome
Cmax of unconjugated and total dabigatran when given without or together with a single oral dose of elinzanetant
Time frame: Pre-dose and up until 72 hours post-dose of DBG etexilate
Cmax: maximum observed drug concentration in plasma after single dose
AUC of unconjugated and total dabigatran when given without or together with a single oral dose of elinzanetant
Time frame: Pre-dose and up until 72 hours post-dose of DBG etexilate
AUC(0-tlast) will be the primary endpoint if AUC cannot be determined in all participants. AUC: area under the concentration vs. time curve from zero to infinity after single dose; AUC(0-tlast): area under the concentration vs. time curve from zero to last quantifiable concentration after single dose
2 secondary outcomes
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: After first study intervention in Period 1 and up to 72.5 hours post-dose of elinzanetant in Period 2 (around 8 days)
Number of participants with treatment-emergent adverse events (TEAEs) categorized by severity
Time frame: After first study intervention in Period 1 and up to 72.5 hours post-dose of elinzanetant in Period 2 (around 8 days)
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 22 Nov 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.vivli.org 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 member 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 Dabigatran etexilate 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 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 5 inclusion and 8 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 22 Nov 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?
Cmax of unconjugated and total dabigatran when given without or together with a single oral dose of elinzanetant (time frame: Pre-dose and up until 72 hours post-dose of DBG etexilate). The study lists 2 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 22 Nov 2022.