Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenPhase 1NCT04889287
A Study to Learn How Much Rosuvastatin Gets Into the Blood When Taken With or Without Elinzanetant and to Learn About the Safety of Elinzanetant in Healthy Participants
A Phase 1 study testing Elinzanetant (BAY3427080) and Rosuvastatin 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, 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 to 65 years, men 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) and Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 26 May 2021to 29 Sep 2021
- 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
- Men only
- 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, laboratory tests, and ECG, vital signs, respiratory rate and body temperature.Weight.
- 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.
- Contraceptive use by men or female partners of male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies:
- -- a. Male participants:
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- 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 until 7 days after the last dose of study intervention.
- Female partners of childbearing potential of male participants do not need to follow special precautions.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Who cannot join
- 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.
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal.
- Use of any systemic or topical medicines or substances which oppose the study objectives, or which might influence them (for further information, see Section 6.8) within 4 weeks prior to screening.
- Participants with positive serology for any of hepatitis B, hepatitis C, of HIV.
- Clinically relevant deviations of the screened safety laboratory parameters in clinical chemistry, hematology, or urinalysis from reference ranges.
- Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular (AV) block, prolongation of the QRS complex over 120 msec or QT interval frequency-corrected according to Bazett's formula (QTcB) -prolongation over 450 msec at screening.
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- Participants with a presence of any of the following, confirmed by a repeat test: AST, alanine aminotransferase (ALT) and/or bilirubin above 1.2 x upper limit of normal (ULN) (at screening or Day -1).
- Known intolerance to statins.
- Current or medical history of myopathy, rhabdomyolysis or myasthenia.
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, One-sequence Crossover Study to Determine the Effects of Multiple Doses of Elinzanetant on the Pharmacokinetics of Rosuvastatin in Healthy Participants
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. Rosuvastatin is already approved for doctors to prescribe and is used to treat high cholesterol levels and prevent heart problems. It is important for researchers to know if taking elinzanetant will affect how other drugs work in the body. Researchers regularly use rosuvastatin in studies to learn how it affects drugs like elinzanetant.In this study, the researchers will study how much elinzanetant gets into the participants' blood when taken with or without rosuvastatin. The study will include about 16 male participants who are between 18 and 65 years old. The participants will all take 5 milligrams (mg) of rosuvastatin and 120 mg of elinzanetant as capsules by mouth. On some days, they will take only rosuvastatin or only elinzanetant. On other days, they will take both study treatments. Each participant will be in the study for up to 6 weeks. But, the entire study will last about 2.5 months.
During the study, all of the participants will stay at the study site for 17 days. 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 how their well being and taken medications.
- Being tested
- Elinzanetant (BAY3427080), Rosuvastatin
- Keywords
- Vasomotor symptoms
- 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
Once daily over 12 days
RosuvastatinDrug
Single doses on Day 1, Day 8, and Day 13
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin and/or elinzanetant | Experimental | The participants will receive each dose of rosuvastatin and/or elinzanetant together with 240 mL of non-sparkling water in total. Receives: Drug: Elinzanetant (BAY3427080); Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of rosuvastatin when given without or together with elinzanetant
Measured: Day 1-3, Day 8-16
Area under the concentration versus time curve (AUC) of rosuvastatin when given without or together with elinzanetant
Measured: Day 1-3, Day 8-16
Secondary outcomes (2)
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Approximately 2.5 months
Severity of treatment-emergent adverse events (TEAEs)
Measured: Approximately 2.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start26 May 2021
- Primary completion23 Jul 2021
- Study completion29 Sep 2021
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
- Not applicable
- Intervention model
- Sequential
- 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
- NCT04889287
- Sponsor's protocol ID
- 21666
- Other IDs
- 2020-004635-25
- Status last verified
- Aug 2023
- First submitted
- 14 May 2021
- Last updated
- 9 Aug 2023
- 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 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, One-sequence Crossover Study to Determine the Effects of Multiple Doses of Elinzanetant on the Pharmacokinetics of Rosuvastatin in Healthy Participants
- ClinicalTrials.gov ID
- NCT04889287
- Acronym / sponsor ID
- 21666
- Keywords
- Vasomotor symptoms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 26 May 2021 (actual)
- Primary completion
- 23 Jul 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 17 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. Rosuvastatin is already approved for doctors to prescribe and is used to treat high cholesterol levels and prevent heart problems. It is important for researchers to know if taking elinzanetant will affect how other drugs work in the body. Researchers regularly use rosuvastatin in studies to learn how it affects drugs like elinzanetant.In this study, the researchers will study how much elinzanetant gets into the participants' blood when taken with or without rosuvastatin. The study will include about 16 male participants who are between 18 and 65 years old. The participants will all take 5 milligrams (mg) of rosuvastatin and 120 mg of elinzanetant as capsules by mouth. On some days, they will take only rosuvastatin or only elinzanetant. On other days, they will take both study treatments. Each participant will be in the study for up to 6 weeks. But, the entire study will last about 2.5 months.
During the study, all of the participants will stay at the study site for 17 days. 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 how their well being and taken medications.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin and/or elinzanetant | Experimental | Drug: Elinzanetant (BAY3427080), Drug: RosuvastatinThe participants will receive each dose of rosuvastatin and/or elinzanetant together with 240 mL of non-sparkling water in total. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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, laboratory tests, and ECG, vital signs, respiratory rate and body temperature.Weight.
- 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.
- Contraceptive use by men or female partners of male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies:
Key exclusion criteria (9 listed)
- 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.
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal.
- Use of any systemic or topical medicines or substances which oppose the study objectives, or which might influence them (for further information, see Section 6.8) within 4 weeks prior to screening.
- Participants with positive serology for any of hepatitis B, hepatitis C, of HIV.
- Clinically relevant deviations of the screened safety laboratory parameters in clinical chemistry, hematology, or urinalysis from reference ranges.
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)Once daily over 12 days | Drug | Rosuvastatin and/or elinzanetant |
| RosuvastatinSingle doses on Day 1, Day 8, and Day 13 | Drug | Rosuvastatin and/or elinzanetant |
Primary outcome
Maximum plasma concentration (Cmax) of rosuvastatin when given without or together with elinzanetant
Time frame: Day 1-3, Day 8-16
Area under the concentration versus time curve (AUC) of rosuvastatin when given without or together with elinzanetant
Time frame: Day 1-3, Day 8-16
2 secondary outcomes
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Approximately 2.5 months
Severity of treatment-emergent adverse events (TEAEs)
Time frame: Approximately 2.5 months
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 9 Aug 2023.
- 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 Rosuvastatin 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 9 inclusion and 9 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 9 Aug 2023. 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?
Maximum plasma concentration (Cmax) of rosuvastatin when given without or together with elinzanetant (time frame: Day 1-3, Day 8-16). 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 9 Aug 2023.