Recruiting
Phase 1

Elinzanetant vs. Elinzanetant

Sponsor:

Bayer

Code:

NCT07762287

Conditions

Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Elinzanetant (BAY 3427080) treatment A

Elinzanetant (BAY 3427080) treatment B

Study Details

Brief summary:

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.

Conditions

Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women

Study ID

NCT07762287

Start date

Jul 22, 2026

Status verified date

Aug, 2026

Completion date

Feb 22, 2027

Anticipated

Primary completion date

Feb 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Elinzanetant (BAY 3427080) treatment A

Elinzanetant treatment A is administered orally once daily.

Elinzanetant (BAY 3427080) treatment B

Elinzanetant treatment B is administered orally once daily.

Primary outcome measure

  • Area Under the Plasma Concentration-Time Curve Over 24 Hours After Multiple Dosing (AUC(0-24)md) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10) ]

Central Contacts and Locations

Central contacts

Bayer Clinical Trials Contact

(+)1-888-84 22937clinical-trials-contact@bayer.com

Locations

Altasciences

Recruiting

Mount Royal, Quebec, Canada, H3P 3P1

More Information

Sponsor

Bayer

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bayer on 2026-08-13.