Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenPhase 1NCT04903821
A Study to Learn How Different Levels of Decreased Liver Function Influence Blood Levels of Elinzanetant Compared to Normal Liver Function in Male and Female Participants
A Phase 1 study testing BAY3427080 in people with Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, run by Bayer at 2 sites in Germany.
Trial summary
Researchers are looking for a better way to treat people who have symptoms caused by hormonal changes, like those that happen in women during menopause. These symptoms can include vasomotor symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy 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?
- BAY3427080
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jun 2021to 15 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
- Participants who have
- Impaired hepatic function according to Child-Pugh score A or B,
- Documented medical history of liver cirrhosis confirmed by either histopathology, laparoscopy, fibroscan, computer tomography, magnetic resonance imaging (MRI), or ultrasound,
- Stable impairment for at least 2 months prior to screening in the judgment of the investigator.
- Participants who have normal hepatic function and are overtly healthy.
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- Body weight of at least 50 kg and BMI within the range 18 to 38 kg/m*2 (inclusive).
- Male or 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 heterosexually active. This applies for the time period between the signing of the informed consent form (ICF) until 7 days after the last dose of study intervention.
- Female partners of male participants do not need to follow special precautions.
- Female participants of childbearing potential: have to agree to use a highly effective non-hormonal contraception when heterosexually active. This applies for the time between signing the ICF until 21 days after the last dose of study intervention (for details and definitions of childbearing potential and allowed contraceptive methods).
- Female participants of childbearing potential must have a negative pregnancy test at screening and on Day -1.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Who cannot join
- Ascites qualitatively estimated as severe or requiring acute or frequent paracentesis.
- Renal failure with an estimated glomerular filtration rate (eGFR) <= 40 mL/min according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- Encephalopathy of > grade 2.
- Renal failure with an eGFR <=60 mL/min CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.
- Any clinically relevant disease (other than those related to hepatic impairment for the hepatic impaired participants) within 4 weeks prior to study drug administration including.
- Medically relevant infections and acute gastro-intestinal diseases (vomiting, diarrhea, constipation).
- Severe cerebrovascular or cardiovascular disorders less than 6 months prior to dosing, e.g., stroke, myocardial infarction, unstable angina pectoris, congestive heart failure of grade III or IV according to New York Heart Association (NYHA), arrhythmia requiring antiarrhythmic treatment, percutaneous transluminal coronary angioplasty or coronary artery bypass graft.
- Febrile illness within 1 week before first study drug administration.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, 24105
APEX GmbH
München, Bavaria, 81241
About this study
Official title: Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Elinzanetant in Participants With Impaired Hepatic Function (Classified as Child-Pugh A or B) in Comparison to Matched Controls With Normal Hepatic Function.
Researchers are looking for a better way to treat people who have symptoms caused by hormonal changes, like those that happen in women during menopause. These symptoms can include vasomotor symptoms. 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.
The study drug, elinzanetant, was designed to treat vasomotor symptoms. The liver plays an important role in removing elinzanetant from the body. Therefore, this study is done to find out how reduced liver function influences the removal of elinzanetant.
Read more
The study will include male and female participants who are 18 to 75 years old. One part of the participants will have mildly or moderately impaired hepatic function. For each group with impaired hepatic function, a group with normal hepatic function will be included.
Blood and urine samples will be collected. The physician will also check the participants' heart health using an electrocardiogram (ECG). The participants will answer questions about their well-being and taken medications.
The researchers will compare the blood levels of elinzanetant in the participants with impaired hepatic function to those of the matched participants with normal hepatic function. This way, they can see how blood levels of elinzanetant are influenced by liver function. This information is important for giving recommendations on dosing in patients with impaired hepatic function.
- Being tested
- BAY3427080
- 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.
BAY3427080Drug
Orally administered, single dose on Day 1 and single does once daily on Day 3 to 8
| Study group | Role | What they receive |
|---|---|---|
| Group A (Child- Pugh A) | Experimental | Participants with mild impaired hepatic function (Child-Pugh A), including at least 2 female participants. Receives: Drug: BAY3427080 |
| Group B (Child-Pugh B) | Experimental | Participants with moderate impaired hepatic function (Child-Pugh B), including at least 2 female participants Receives: Drug: BAY3427080 |
| Control A match controls for group A | Experimental | Matched control participants for Group A with normal hepatic function. Receives: Drug: BAY3427080 |
| Control B match controls for group B | Experimental | Matched control participants for Group B with normal hepatic function Receives: Drug: BAY3427080 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,md,u of elinzanetant
Cmax,md,u: Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval of the unbound analyte.
Measured: On day 8
AUC(0-24)md,u of elinzanetant
AUC: Area under the curve extrapolated to infinity. AUC(0-24)md,u: AUC from time 0 to 24 after multiple dosing of the unbound analyte.
Measured: On day 8
Secondary outcomes (4)
Incidence of treatmentemergent adverse events (TEAEs)
Measured: About 10 months
Severity of treatmentemergent adverse events (TEAEs)
Measured: About 10 months
AUCu of elinzanetant
Or AUC(0-tlast) if AUC cannot be determined. AUCu: AUC extrapolated to infinity of the unbound analyte. AUC(0-tlast): AUC from time 0 to the last data point > LLOQ (lower limit of quantification)
Measured: On Day 1
Cmax,u of elinzanetant
Cmax,u: Maximum observed drug concentration in measured matrix after single dose administration of the unbound analyte.
Measured: On Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Jun 2021
- Primary completion15 Mar 2022
- Study completion15 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903821
- Sponsor's protocol ID
- 21668
- Other IDs
- 2020-005939-74
- Status last verified
- Mar 2022
- First submitted
- 24 May 2021
- Last updated
- 24 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 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Elinzanetant in Participants With Impaired Hepatic Function (Classified as Child-Pugh A or B) in Comparison to Matched Controls With Normal Hepatic Function.
- ClinicalTrials.gov ID
- NCT04903821
- Acronym / sponsor ID
- 21668
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 27 May 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, like those that happen in women during menopause. These symptoms can include vasomotor symptoms. 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.
The study drug, elinzanetant, was designed to treat vasomotor symptoms. The liver plays an important role in removing elinzanetant from the body. Therefore, this study is done to find out how reduced liver function influences the removal of elinzanetant.
The study will include male and female participants who are 18 to 75 years old. One part of the participants will have mildly or moderately impaired hepatic function. For each group with impaired hepatic function, a group with normal hepatic function will be included.
Blood and urine samples will be collected. The physician will also check the participants' heart health using an electrocardiogram (ECG). The participants will answer questions about their well-being and taken medications.
The researchers will compare the blood levels of elinzanetant in the participants with impaired hepatic function to those of the matched participants with normal hepatic function. This way, they can see how blood levels of elinzanetant are influenced by liver function. This information is important for giving recommendations on dosing in patients with impaired hepatic function.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A (Child- Pugh A) | Experimental | Drug: BAY3427080Participants with mild impaired hepatic function (Child-Pugh A), including at least 2 female participants. |
| Group B (Child-Pugh B) | Experimental | Drug: BAY3427080Participants with moderate impaired hepatic function (Child-Pugh B), including at least 2 female participants |
| Control A match controls for group A | Experimental | Drug: BAY3427080Matched control participants for Group A with normal hepatic function. |
| Control B match controls for group B | Experimental | Drug: BAY3427080Matched control participants for Group B with normal hepatic function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participant must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
- Participants who have
- Participants who have normal hepatic function and are overtly healthy.
- Body weight of at least 50 kg and BMI within the range 18 to 38 kg/m*2 (inclusive).
- Male or 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 (8 listed)
- Ascites qualitatively estimated as severe or requiring acute or frequent paracentesis.
- Renal failure with an estimated glomerular filtration rate (eGFR) <= 40 mL/min according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- Encephalopathy of > grade 2.
- Renal failure with an eGFR <=60 mL/min CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.
- Any clinically relevant disease (other than those related to hepatic impairment for the hepatic impaired participants) within 4 weeks prior to study drug administration including.
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 |
|---|---|---|
| BAY3427080Orally administered, single dose on Day 1 and single does once daily on Day 3 to 8 | Drug | Control A match controls for group A, Control B match controls for group B, Group A (Child- Pugh A), Group B (Child-Pugh B) |
Primary outcome
Cmax,md,u of elinzanetant
Time frame: On day 8
Cmax,md,u: Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval of the unbound analyte.
AUC(0-24)md,u of elinzanetant
Time frame: On day 8
AUC: Area under the curve extrapolated to infinity. AUC(0-24)md,u: AUC from time 0 to 24 after multiple dosing of the unbound analyte.
4 secondary outcomes
Incidence of treatmentemergent adverse events (TEAEs)
Time frame: About 10 months
Severity of treatmentemergent adverse events (TEAEs)
Time frame: About 10 months
AUCu of elinzanetant
Time frame: On Day 1
Cmax,u of elinzanetant
Time frame: On Day 1
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 24 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY3427080 in people with Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, run by Bayer at 2 sites 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 14 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 24 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 2 sites 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,md,u of elinzanetant (time frame: On day 8). 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 24 Mar 2022.