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

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.

Study Overview

• Status: Recruiting
• Conditions: Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women
• Intervention / Treatment: Drug: Elinzanetant (BAY 3427080) treatment A; Drug: Elinzanetant (BAY 3427080) treatment B

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Canada
  • Quebec
    • Mount Royal, Quebec, Canada, H3P 3P1
      • Recruiting
      • Altasciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Elinzanetant (BAY 3427080) treatment A; Elinzanetant treatment A is administered orally once daily.; Drug: Elinzanetant (BAY 3427080) treatment B; Elinzanetant treatment B is administered orally once daily.
Experimental: 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.	Drug: Elinzanetant (BAY 3427080) treatment A; Elinzanetant treatment A is administered orally once daily.; Drug: Elinzanetant (BAY 3427080) treatment B; Elinzanetant treatment B is administered orally once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Plasma Concentration-Time Curve Over 24 Hours After Multiple Dosing (AUC(0-24)md)	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)	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)	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Severity of Treatment-Emergent Adverse Events (TEAEs)		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))	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)	elinzanetant administered in the evening under fasted conditions.	On Day 2 of each 12-day treatment period

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2026
• Primary Completion (Estimated): February 22, 2027
• Study Completion (Estimated): February 22, 2027

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: August 8, 2026
• First Posted (Actual): August 13, 2026

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 8, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 22791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No