Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenPhase 1NCT05481528
A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy Participants
A Phase 1 study testing Moxifloxacin and 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 Germany.
Trial summary
Researchers are looking for a better way to treat vasomotor symptoms, a condition of having hot flashes. The condition is caused by hormonal changes and occurs primarily in women, but can also affect men. The study treatment, elinzanetant, is under development to treat symptoms caused by hormonal changes. Read more about this study
- Who is it for?
- Ages 18 to 55 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?
- Moxifloxacin and Elinzanetant (BAY3427080)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteGermany
- Study dates
- 19 Aug 2022to 28 Apr 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate, respiratory rate, body temperature and electrocardiogram (ECG).
- Body weight of at least 50 kg.
- Body mass index (BMI) within the range 18.0 to 30.0 kg/m^2 (inclusive).
- Male subjects of reproductive potential must agree to use a condom (with or without spermicide) when sexually active with a female partner and refrain from donating sperm. This applies for the time period between the signing of the informed consent form (ICF) until 5 days after the last administration of study intervention. Female partners of childbearing potential of male subjects do not need to follow special precautions.
- Women of childbearing potential will have to use a highly effective non-hormonal contraception when having sexual intercourse with a male partner from signing of the ICF until 5 days after the last administration of study intervention.
Who cannot join
- Any clinically relevant abnormal findings in medical history and physical examination. Including: 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; Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal.
- Known or suspected hypersensitivity or allergy to the study interventions or other fluoroquinolone products.
- Relevant diseases within the last 4 weeks prior to the first administration of study intervention, including febrile illness.
- Contraindications for the use of moxifloxacin, including: Medical history of seizures or psychiatric disorders, myasthenia gravis, severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN; also known as Lyell's syndrome), Stevens Johnson syndrome (SJS) and Acute Generalized Exanthematous Pustulosis (AGEP), glucose-6-phosphate dehydrogenase deficiency.
- Pregnant or breastfeeding women.
- Tendency for vasovagal reactions or history of syncope.
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- Use of mild, moderate, or strong CYP3A4 and P-gp inhibitors from 2 weeks, and use of CYP3A4 and P-gp inducers from 4 weeks prior to the first administration of study intervention.
- Use of drugs which may affect absorption and systemic administration of any broad-spectrum antibiotic within 1 week prior to first administration of study intervention.
- Use of drugs which may affect absorption by increasing the gastrointestinal pH e.g. proton pump inhibitors from 2 weeks prior to first administration of study intervention.
- Use of any herbal products or St. John's wort within 4 weeks prior to the first administration of study intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo- and Moxifloxacin-controlled Study to Investigate the Safety and Pharmacokinetics of Single Ascending Supratherapeutic Doses of Elinzanetant in Healthy Participants
Researchers are looking for a better way to treat vasomotor symptoms, a condition of having hot flashes. The condition is caused by hormonal changes and occurs primarily in women, but can also affect men.
The study treatment, 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 it in people with vasomotor symptoms.
In previous studies, elinzanetant doses tested and resulting blood levels were close to the levels intended for treatment. However, in future use, it cannot always be ruled out that higher elinzanetant concentrations may occur in the blood if patients are taking certain other drugs at the same time, or take more than the recommended dose of the drug.
The main purpose of this study is to learn how safe elinzanetant is when higher doses than normally used are given compared to placebo in healthy participants. A placebo is a treatment that looks like a medicine but does not have any medicine in it.
To answer this, researchers will compare the number of participants who have medical problems after taking elinzanetant to those treated with placebo. Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.
The study consists of two parts. In part 1, the participants will either take a single dose of elinzanetant or placebo by mouth dependent on the treatment group. Four different increasing doses of elinzanetant will be tested.
Participants in dose group 1 and 4 will participate in part 2. About 8 days after treatment in part 1, the participants will receive a single dose of moxifloxacin and a single dose of placebo as tablet by mouth 5 days apart. Whether the participant starts with moxifloxacin or placebo is decided by chance. Moxifloxacin is used to make sure that certain changes in heart rhythm can be detected in the study.
Each participant will be in the study for about 6 weeks including 1 treatment day (part 1) or for about 8 weeks including 3 treatment days (part 1 \& 2). Participants of part 1 will stay in-house for 7 days. Participants of part 2 will stay in-house for another 9 days. The in-house phase starts two days before intake of the study treatment. In addition, one visit before and one visit after the in-house phase to the study site is planned.
During the study, the study team will:
- Do physical examinations
- Check vital signs
- Take blood and urine samples
- Examine the participants' heart health using electrocardiogram (ECG)
- Ask the participants questions about their mood and about sleepiness.
- Conditions
- Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes, Healthy Volunteers
- Being tested
- Moxifloxacin, 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.
MoxifloxacinDrug
Single oral dose of 400 mg moxifloxacin
Elinzanetant (BAY3427080)Drug
Single oral dose of elinzanetant
PlaceboDrug
Single oral dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Dose group 1 | Experimental | Single oral dose of elinzanetant or placebo. Receives: Drug: Elinzanetant (BAY3427080); Drug: Placebo |
| Part 1 - Dose group 2 | Experimental | Single oral dose of elinzanetant or placebo Receives: Drug: Elinzanetant (BAY3427080); Drug: Placebo |
| Part 1 - Dose group 3 | Experimental | Single oral dose of elinzanetant or placebo Receives: Drug: Elinzanetant (BAY3427080); Drug: Placebo |
| Part 1 - Dose group 4 | Experimental | Single oral dose of elinzanetant or placebo Receives: Drug: Elinzanetant (BAY3427080); Drug: Placebo |
| Part 2: Moxifloxacin - Placebo | Experimental | Participants of Dose Groups 1 and 4 will receive a single dose of moxifloxacin in Period 1 and a single dose of placebo in Period 2. Receives: Drug: Moxifloxacin; Drug: Placebo |
| Part 2: Placebo - Moxifloxacin | Experimental | Participants of Dose Groups 1 and 4 will receive a single dose of placebo in Period 1 and a single dose of moxifloxacin in Period 2. Receives: Drug: Moxifloxacin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs) and severity of TEAEs related to elinzanetant
Measured: After first application of study intervention until 20 days after last application of study intervention
Secondary outcomes (2)
AUC (if AUC cannot be determined reliably in all subjects, AUC(0-tlast) will be used instead) of elinzanetant
AUC stands for area under the concentration versus time curve from zero to infinity
Measured: 0 - 96 hours post-dose
Cmax of elinzanetant
Cmax stands for maximum observed concentration
Measured: 0 - 96 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start19 Aug 2022
- Primary completion7 Feb 2023
- Study completion28 Apr 2023
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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481528
- Sponsor's protocol ID
- 21670
- Other IDs
- 2022-000056-11
- Status last verified
- May 2023
- First submitted
- 28 Jul 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data 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 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo- and Moxifloxacin-controlled Study to Investigate the Safety and Pharmacokinetics of Single Ascending Supratherapeutic Doses of Elinzanetant in Healthy Participants
- ClinicalTrials.gov ID
- NCT05481528
- Acronym / sponsor ID
- 21670
- 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
- 51 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 1 Aug 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 vasomotor symptoms, a condition of having hot flashes. The condition is caused by hormonal changes and occurs primarily in women, but can also affect men.
The study treatment, 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 it in people with vasomotor symptoms.
In previous studies, elinzanetant doses tested and resulting blood levels were close to the levels intended for treatment. However, in future use, it cannot always be ruled out that higher elinzanetant concentrations may occur in the blood if patients are taking certain other drugs at the same time, or take more than the recommended dose of the drug.
The main purpose of this study is to learn how safe elinzanetant is when higher doses than normally used are given compared to placebo in healthy participants. A placebo is a treatment that looks like a medicine but does not have any medicine in it.
To answer this, researchers will compare the number of participants who have medical problems after taking elinzanetant to those treated with placebo. Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.
The study consists of two parts. In part 1, the participants will either take a single dose of elinzanetant or placebo by mouth dependent on the treatment group. Four different increasing doses of elinzanetant will be tested.
Participants in dose group 1 and 4 will participate in part 2. About 8 days after treatment in part 1, the participants will receive a single dose of moxifloxacin and a single dose of placebo as tablet by mouth 5 days apart. Whether the participant starts with moxifloxacin or placebo is decided by chance. Moxifloxacin is used to make sure that certain changes in heart rhythm can be detected in the study.
Each participant will be in the study for about 6 weeks including 1 treatment day (part 1) or for about 8 weeks including 3 treatment days (part 1 \& 2). Participants of part 1 will stay in-house for 7 days. Participants of part 2 will stay in-house for another 9 days. The in-house phase starts two days before intake of the study treatment. In addition, one visit before and one visit after the in-house phase to the study site is planned.
During the study, the study team will:
- Do physical examinations
- Check vital signs
- Take blood and urine samples
- Examine the participants' heart health using electrocardiogram (ECG)
- Ask the participants questions about their mood and about sleepiness.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Dose group 1 | Experimental | Drug: Elinzanetant (BAY3427080), Drug: PlaceboSingle oral dose of elinzanetant or placebo. |
| Part 1 - Dose group 2 | Experimental | Drug: Elinzanetant (BAY3427080), Drug: PlaceboSingle oral dose of elinzanetant or placebo |
| Part 1 - Dose group 3 | Experimental | Drug: Elinzanetant (BAY3427080), Drug: PlaceboSingle oral dose of elinzanetant or placebo |
| Part 1 - Dose group 4 | Experimental | Drug: Elinzanetant (BAY3427080), Drug: PlaceboSingle oral dose of elinzanetant or placebo |
| Part 2: Moxifloxacin - Placebo | Experimental | Drug: Moxifloxacin, Drug: PlaceboParticipants of Dose Groups 1 and 4 will receive a single dose of moxifloxacin in Period 1 and a single dose of placebo in Period 2. |
| Part 2: Placebo - Moxifloxacin | Experimental | Drug: Moxifloxacin, Drug: PlaceboParticipants of Dose Groups 1 and 4 will receive a single dose of placebo in Period 1 and a single dose of moxifloxacin in Period 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate, respiratory rate, body temperature and electrocardiogram (ECG).
- Body weight of at least 50 kg.
- Body mass index (BMI) within the range 18.0 to 30.0 kg/m^2 (inclusive).
- Male subjects of reproductive potential must agree to use a condom (with or without spermicide) when sexually active with a female partner and refrain from donating sperm. This applies for the time period between the signing of the informed consent form (ICF) until 5 days after the last administration of study intervention. Female partners of childbearing potential of male subjects do not need to follow special precautions.
- Women of childbearing potential will have to use a highly effective non-hormonal contraception when having sexual intercourse with a male partner from signing of the ICF until 5 days after the last administration of study intervention.
Key exclusion criteria (10 listed)
- Any clinically relevant abnormal findings in medical history and physical examination. Including: 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; Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal.
- Known or suspected hypersensitivity or allergy to the study interventions or other fluoroquinolone products.
- Relevant diseases within the last 4 weeks prior to the first administration of study intervention, including febrile illness.
- Contraindications for the use of moxifloxacin, including: Medical history of seizures or psychiatric disorders, myasthenia gravis, severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN; also known as Lyell's syndrome), Stevens Johnson syndrome (SJS) and Acute Generalized Exanthematous Pustulosis (AGEP), glucose-6-phosphate dehydrogenase deficiency.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| MoxifloxacinSingle oral dose of 400 mg moxifloxacin | Drug | Part 2: Moxifloxacin - Placebo, Part 2: Placebo - Moxifloxacin |
| Elinzanetant (BAY3427080)Single oral dose of elinzanetant | Drug | Part 1 - Dose group 1, Part 1 - Dose group 2, Part 1 - Dose group 3, Part 1 - Dose group 4 |
| PlaceboSingle oral dose of placebo | Drug | Part 1 - Dose group 1, Part 1 - Dose group 2, Part 1 - Dose group 3, Part 1 - Dose group 4, Part 2: Moxifloxacin - Placebo, Part 2: Placebo - Moxifloxacin |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs) and severity of TEAEs related to elinzanetant
Time frame: After first application of study intervention until 20 days after last application of study intervention
2 secondary outcomes
AUC (if AUC cannot be determined reliably in all subjects, AUC(0-tlast) will be used instead) of elinzanetant
Time frame: 0 - 96 hours post-dose
Cmax of elinzanetant
Time frame: 0 - 96 hours post-dose
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 May 2023.
- Individual participant dataSharing planned: Undecided. Availability of this study's data 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 Moxifloxacin and 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 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 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 9 May 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?
Number of participants with treatment-emergent adverse events (TEAEs) and severity of TEAEs related to elinzanetant (time frame: After first application of study intervention until 20 days after last application of study intervention). 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 May 2023.