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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
Single oral dose
Single oral dose
CRS Clinical-Research-Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany
AUC of elinzanetant
AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose
Time frame: Period 1: Day 1-9, Day 11, Day 13, Day 15; Period 2: Day 1-7, Day 8 (follow up visit)
Cmax of elinzanetant
Cmax: Maximum observed drug concentration in measured matrix after single dose administration
Time frame: Period 1: Day 1-9, Day 11, Day 13, Day 15; Period 2: Day 1-7, Day 8 (follow up visit)
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Approximately 2 to 3 months
Severity of treatment-emergent adverse events (TEAEs)
Time frame: Approximately 2 to 3 months
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