NCT04845841

Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body

Single Center, Randomized, Open-label, Cross-over Study to Investigate the Pharmacokinetics of Two Oral Formulations of Elinzanetant After Single Dosing in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Researchers are looking for a new way to treat women who have symptoms by hormonal changes, like those that happen in women during menopause. These symptoms can include hot flashes, night sweats, and changes in blood pressure. These symptoms are caused by hormonal changes occurring during menopausal transition when women may have also changes in their monthly cycles. The menopausal transition most often begins between ages 45 and 55 and leads to menopause, a point in time 12 months after a woman's last period. The study drug, elinzanetant, was designed to treat symptoms caused by hormonal changes. Before a new treatment can be approved for people to take, researchers perform clinical trials to better understand how this treatment works and to investigate safety. The purpose of this study is to assess the blood levels of elinzanetant when given as 2 capsules of dose A (what is intended for further research and future commercialization) and also to compare the blood levels when given as 3 capsules of dose B (what was used for research up to now). Furthermore, researchers want to find out if taking of elinzanetant on two time points leads to differences in blood levels of elinzanetant. This trial will be performed in healthy women aged 40 to 65 years.

Conditions

• Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men

Interventions

Type	Name	Description
DRUG	Elinzanetant (BAY3427080) treatment A	Single oral dose
DRUG	Elinzanetant (BAY3427080) treatment B	Single oral dose

Timeline

• Start date: 2021-04-09
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2021-04-15
• Last updated: 2023-08-09

Locations

1 site across 1 country: Germany