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Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants

8 augusti 2026 uppdaterad av: 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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • Quebec
      • Mount Royal, Quebec, Kanada, H3P 3P1
        • Rekrytering
        • Altasciences

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Area Under the Plasma Concentration-Time Curve Over 24 Hours After Multiple Dosing (AUC(0-24)md)
Tidsram: 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)
Maximum Observed Plasma Concentration After Multiple Dosing (Cmax,md)
Tidsram: 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)
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number and Severity of Treatment-Emergent Adverse Events (TEAEs)
Tidsram: 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)
Area Under the Plasma Concentration-Time Curve Over 24 Hours After Single Dose (AUC(0-24))
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 juli 2026

Primärt slutförande (Beräknad)

22 februari 2027

Avslutad studie (Beräknad)

22 februari 2027

Studieregistreringsdatum

Först inskickad

15 juli 2026

Först inskickad som uppfyllde QC-kriterierna

8 augusti 2026

Första postat (Faktisk)

13 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 22791

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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