A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 Years

Sponsor
Bayer
Study ID
NCT05381142
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers
  • Hot Flashes
  • Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Elinzanetant (BAY3427080) — DRUG
    Elinzanetant will be administered as a single dose on Study Day 1 and a multiple dose once daily for another 6 consecutive days on Study Day 8 to Study Day 13.
  • Placebo — DRUG
    Matching placebo will be administered the same as Elinzanetant (BAY3427080)

Study Details

Researchers are looking for a better way to treat men and women with vasomotor symptoms, a condition of having hot flashes caused by hormonal changes. In women, these hormonal changes happen in the time around their menopause, the last period (menstrual cycle) a woman has. After the menopause, the ovaries produce less and less sex hormones as a result of the natural ageing process and related hormonal adaptations. The decrease in hormones produced can lead to various symptoms that may be troublesome. Vasomotor symptoms are also seen in men. The study treatment, elinzanetant, is under development to treat symptoms caused by hormonal changes. It works by blocking a substance called neurokinin, which is thought to play a role in starting hot flashes. Previous studies have been done. This study will provide information on how to use elinzanetant in Chinese people. The main purpose of this study is to learn how much of the study treatment elinzanetant gets into the participants' blood when a single dose is taken in healthy Chinese women. To answer this question, the researchers will measure: * The (average) total level of elinzanetant in the blood (also called AUC) * The (average) highest level of elinzanetant in the blood (also called Cmax) The researchers also want to learn how much elinzanetant gets into the blood when taken for 6 days in a row. Dependent on the treatment group, the participants will either take elinzanetant or placebo. First, a single dose of two capsules is taken by mouth and later multiple doses once a day for another 6 days in a row are taken. Each participant will be in the study for approximately 22 days including 7 treatment days in total. Participants will stay in-house for 16 days. In addition, one visit to the study site prior start and four visits after the in-house period are planned. During the study, the study team will: * Do physical examinations * Take blood and urine samples * Check vital signs * Examine the participants' heart health using electrocardiogram (ECG) * Ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

Key Dates

First listed
May 19, 2022
Start date
May 23, 2022
Status verified
Jul 2022
Primary completion
Jul 11, 2022
Completion
Jul 11, 2022

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Elinzanetant (BAY3427080)
    Healthy female participants who meet all of the inclusion criteria and do not meet any of the exclusion criteria will be randomized to treatment with elinzanetant.
  • Placebo Comparator: Placebo
    Healthy female participants who meet all of the inclusion criteria and do not meet any of the exclusion criteria will be randomized and assigned to treatment with placebo.

Primary Outcome Measure

Cmax: maximum observed drug concentration in measured matrix after single dose administration [ Time Frame: From pre-dose up to 168 hours after first dosing ]

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