A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women

Summary

Researchers are looking for a better way to treat vasomotor symptoms (VMS), also known as hot flashes.

Hot flashes are intense and sudden feelings of heat along with sweating and reddening of the skin. These are common for women going through the menopause but can also occur in men. Such symptoms are called VMS and are caused by changes in sex hormone levels.

The study treatment, elinzanetant, is being tested for the treatment of VMS in both men and women. It works by blocking the activity of a substance called neurokinin, which is thought to play a role in starting hot flashes.

Elinzanetant may cause lasting effects like sleepiness and tiredness. Such effects may make driving unsafe.

The main purpose of this study is to learn how elinzanetant affects the ability to drive the next day in healthy women.

For this, researchers will study participants' ability to keep a stable position within their lane while driving on a straight road on a computer-based driving test (also known as a driving simulator).

In this study, participants will take 2 different doses of elinzanetant, another drug called zopiclone, and matching placebos to these drugs.

Zopiclone helps treat sleeping problems. A placebo looks like a study drug but does not have any medicine in it.

Participants will take elinzanetant, zopiclone, and their matching placebos by mouth.

This study will have 4 treatment periods with each period lasting 6 days. In each period, participants will receive one of the following treatments in an order assigned to them randomly (by chance):

* dose A of elinzanetant and a zopiclone placebo
* dose B of elinzanetant and a zopiclone placebo
* zopiclone 7.5 milligrams (mg) and elinzanetant placebo
* elinzanetant placebo and zopiclone placebo

Each participant will be in the study for around 15 weeks with up to 6 visits to the study site.

Participants will visit the study site:

* once before the treatment starts, so the study doctors and their team can check on their health and confirm if the participant can join the study
* once in each of the 4 treatment periods for a 6-day stay at the study site with a gap of 14 days between each period. During each stay, they will take the assigned treatment from Days 1 to 5 and the driving test on Days 2 and 6
* once, 2 to 3 days after their last treatment so the study doctors and their team can check on their health

During the study, the doctors and their study team will:

* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
* check the participants' ability to drive and their brain function and level of sleepiness using different tests including a driving simulator test
* check the level of the study drugs in participants' blood
* 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, irrespective of whether they think they are related to the study treatment or not.

Conditions

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

Interventions

DRUG

Elinzanetant (BAY3427080)

Oral administration of multiple doses of elinzanetant.

DRUG

Placebo to elinzanetant

Oral administration

DRUG

Zopiclone

Oral administration

DRUG

Placebo to zopiclone

Oral administration

Sponsors & Collaborators

• Bayer

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

40 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-08

Primary Completion

2024-04-15

Completion

2024-04-15

Countries

• Canada

Study Locations