Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants
8 augustus 2026 bijgewerkt door: Bayer
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
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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
100
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Bayer Clinical Trials Contact
- Telefoonnummer: (+)1-888-84 22937
- E-mail: clinical-trials-contact@bayer.com
Studie Locaties
-
-
Quebec
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Mount Royal, Quebec, Canada, H3P 3P1
- Werving
- Altasciences
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Sequence 1: Treatment A followed by Treatment B
Participants receive Treatment A followed by Treatment B in a randomized 2 x 2 crossover design with two treatment periods.
|
Elinzanetant treatment A is administered orally once daily.
Elinzanetant treatment B is administered orally once daily.
|
|
Experimenteel: Sequence 2: Treatment B followed by Treatment A
Participants receive Treatment B followed by Treatment A in a randomized 2 x 2 crossover design with two treatment periods.
|
Elinzanetant treatment A is administered orally once daily.
Elinzanetant treatment B is administered orally once daily.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve Over 24 Hours After Multiple Dosing (AUC(0-24)md)
Tijdsspanne: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
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elinzanetant administered in the evening 3 hours after a light dinner.
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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)
Tijdsspanne: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
|
elinzanetant administered in the evening 3 hours after a light dinner.
|
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)
Tijdsspanne: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
|
elinzanetant administered in the evening 3 hours after a light dinner.
|
On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number and Severity of Treatment-Emergent Adverse Events (TEAEs)
Tijdsspanne: From first dose of study intervention through Day 12 of Period 2 (each treatment period is 12 days)
|
From first dose of study intervention through Day 12 of Period 2 (each treatment period is 12 days)
|
|
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Area Under the Plasma Concentration-Time Curve Over 24 Hours After Single Dose (AUC(0-24))
Tijdsspanne: On Day 2 of each 12-day treatment period
|
elinzanetant administered in the evening under fasted conditions.
|
On Day 2 of each 12-day treatment period
|
|
Maximum Observed Plasma Concentration After Single Dose (Cmax)
Tijdsspanne: On Day 2 of each 12-day treatment period
|
elinzanetant administered in the evening under fasted conditions.
|
On Day 2 of each 12-day treatment period
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
22 juli 2026
Primaire voltooiing (Geschat)
22 februari 2027
Studie voltooiing (Geschat)
22 februari 2027
Studieregistratiedata
Eerst ingediend
15 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
8 augustus 2026
Eerst geplaatst (Werkelijk)
13 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
8 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 22791
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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