Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorBayer
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Elinzanetant (BAY 3427080) treatment A
- Elinzanetant (BAY 3427080) treatment B
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov