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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

NCT05381142 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-07-27

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Elinzanetant (BAY3427080)

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.

DRUG

Placebo

Matching placebo will be administered the same as Elinzanetant (BAY3427080)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2022-07-11
Completion
2022-07-11

Countries

  • China

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05381142 on ClinicalTrials.gov