Comparing Elinzanetant (BAY 3427080) treatment A with Elinzanetant (BAY 3427080) treatment B for vasomotor symptoms as a sex hormone-dependent disorder in
Official title: Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants
A Combined Single- and Multiple-dose, Open-label, Randomized, 2 x 2 Crossover Study to Investigate the Relative Bioavailability of Two Oral Elinzanetant (BAY 3427080) Formulations in Healthy Female Participants
- Phase 1
- 2 groups
- One site, in Mount Royal
- Recruiting
Interventions
- Medication
Elinzanetant (BAY 3427080) treatment A
Elinzanetant treatment A is administered orally once daily.
- Medication
Elinzanetant (BAY 3427080) treatment B
Elinzanetant treatment B is administered orally once daily.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Altasciences
Mount Royal, Quebec
Eligibility Criteria
See who this study is looking for16 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Female participants aged 18 to 65 years (inclusive) at the time of signing informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Participants must be overtly healthy as determined by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → based on medical history, physical examination, vital signs, ECG, and clinical laboratory assessments.
- +Body weight ≥50 kg and body mass index (BMI) between 18.0 and 32.0 kg/m² (inclusive) at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +Signed informed consent obtained prior to any study-specific procedures.
- +Women of childbearing potential must agree to use a highly effective method of contraception during the study and until 14 days after last administration of study intervention.
Exclusion
- −Known or suspected hypersensitivity to the study intervention(s) or their excipients.
- −Severe allergies or clinically significant hypersensitivity reactions (e.g. allergic asthma, urticaria, or steroid-requiring allergies).
- −Diseases or conditions that may affect absorption, distribution, metabolism, elimination, or effects of the study intervention(s).
- −Febrile illness within 2 weeks prior to first administration of study intervention.
- −History of clinically relevant seizures or endometrial tumors.
- −Use of moderate or strong CYP3A4 inhibitors or inducers within 4 weeks prior to first study intervention.
- −Participation in another clinical study within 30 days prior to first study intervention or concurrent participation in another trial.
- −Clinically relevant abnormal laboratory findings at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, including elevated liver enzymes or positive virology tests.
- −Special diets incompatible with study requirements or inability to comply with study procedures.
- −Positive pregnancy test at screening or prior to dosing, or breastfeeding. Positive drug abuse or alcohol test at screening.
- −Smoking more than 10 cigarettes per day within 3 months prior to screening.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Groups A and B receive one or more of: Elinzanetant (BAY 3427080) treatment A and Elinzanetant (BAY 3427080) treatment B.
Registry label: A: Sequence 1: Treatment A followed by Treatment B · B: Sequence 2: Treatment B followed by Treatment A
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 65 years.
The study lists female participants only.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around February 2027.
The main measurement is taken over: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Area Under the Plasma Concentration-Time Curve Over 24 Hours After Multiple Dosing (AUC(0-24)md) — measured over On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10).
Maximum Observed Plasma Concentration After Multiple Dosing (Cmax,md) — measured over On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10).
Minimum Observed Plasma Concentration During Dosing Interval After Multiple Dosing (Cmin,md) — measured over On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07762287 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Elinzanetant (BAY 3427080) treatment ADrug
Elinzanetant treatment A is administered orally once daily.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Elinzanetant (BAY 3427080) treatment BDrug
Elinzanetant treatment B is administered orally once daily.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 65 years.
It lists female participants only.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10).
The study as a whole is currently expected to finish around 2027-02-22.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Mount Royal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study is being done to compare two forms of the medicine elinzanetant, which is used to help manage hot flush symptoms related to changes in female hormones. The researchers want to find out whether a new tablet form of elinzanetant is absorbed and processed by the body of healthy women in a similar way than an existing capsule form. About 100 healthy women aged 18 to 65 will take part in this study. Each participant will receive both forms of the medicine at different times during the study. They will take the medicine once daily for several days under controlled conditions at a study center, and blood samples will be collected to measure how the body absorbs and handles the drug. The study is designed so that each participant can be compared to herself, helping researchers clearly understand any differences between the two formulations.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.