How your body handles two forms of elinzanetant in healthy women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study compares two formulations of elinzanetant (tablet vs. capsule) in about 100 healthy women aged 18–65. Each participant receives both forms at different times, with daily dosing over several days in a controlled center setting. Blood samples will be collected to analyze pharmacokinetics and determine if the tablet form behaves similarly to the capsule. The trial uses a within-subject design to directly compare the two formulations in the same individuals. Results could inform formulation choices for future clinical testing in women experiencing vasomotor symptoms.

Why it matters

Who can join: the full rules

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.

Where it's running

• Altasciences
  Mount Royal, Quebec, Canada Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.