NCT07762287 Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 100 participants in total. It began in 2026-07-22 with a primary completion date of 2027-02-22.

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.

Eligibility Criteria

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.

Contact & Investigator

Frequently Asked Questions

Related Trials