Will a new tablet match the capsule for hot flash relief?
NCT ID NCT07762287
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This study tests whether a new tablet form of elinzanetant, a medicine used to manage hot flashes linked to hormone changes, is absorbed and processed by the body in a similar way to the existing capsule. About 100 healthy women aged 18 to 65 will take both forms at different times, with blood samples measuring how the drug behaves. The goal is to see if the tablet can be a suitable alternative to the capsule.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Elinzanetant (BAY 3427080) in two oral formulations: a new tablet and an existing capsule
- What this could lead to
- If the tablet is absorbed similarly to the capsule, it could offer a more convenient or cost-effective way to deliver this medicine for managing hot flashes.
- What could go wrong
- This is an early-stage study in healthy volunteers, not patients, so results may not predict real-world effectiveness. The tablet might not match the capsule's absorption, and side effects are still being assessed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Female participants aged 18 to 65 years (inclusive) at the time of signing informed consent. * Participants must be overtly healthy as determined by the investigator 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 screening. * 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. * Signed informed consent obtained prior to any study-specific procedures. Exclusion Criteria: * Diseases or conditions that may affect absorption, distribution, metabolism, elimination, or effects of the study intervention(s). * 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). * 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 screening, including elevated liver enzymes or positive virology tests. * 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. * Special diets incompatible with study requirements or inability to comply with study procedures.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Altasciences
RECRUITINGMount Royal, Quebec, H3P 3P1, Canada