Clinical trial NCT06219902: A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women
Official title: A Randomized, Double-blind, Placebo- and Active-controlled, 4-period, Crossover Study to Investigate Effects of Elinzanetant on Simulated Driving Performance and Cognitive Function in Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
Hot Flashes
Keywords: Driving performance,
Cognitive function
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-01-23
Enrollment: 64
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Females aged 40 to 65 years, inclusive, at signing of informed consent.
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and electrocardiogram (ECG).
* Participant has a regular sleep pattern, is not engaged in shift-work, and in general, has at least 7 hours of sleep each night (bedtime occurs between 21:00 and 24:00 hours).
* Participant possesses a valid driver's license and is an active driver. Drives a minimum of 8,000 kilometers per year for the previous 3 years.

Exclusion Criteria:

* Relevant diseases within the last 4 weeks prior to the first administration of study intervention, including febrile illness.
* A history within 2 years of, or current treatment for, a sleeping disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful condition that interferes with the participant's sleep.
* Abnormal finding in the physical examination, ECG, blood pressure, pulse rate or clinical laboratory results at Screening, that are considered clinically significant by the investigator.
* Use of any medication of dietary supplement which may affect central nervous system (CNS) function and may confound the pharmacodynamic assessments of the study.

Primary outcomes:
measure: Simulated driving performance as measured by SDLP using CRCDS-MiniSim
timeFrame: Approximately 9 hours after last dose
Secondary outcomes:
measure: Lane Exceedance: Number of Exceedance.
timeFrame: Approximately 9 hours after last dose
measure: Lane Exceedance: Maximum Duration of Exceedance.
timeFrame: Approximately 9 hours after last dose
measure: Lane Exceedance: Area of Exceedance.
timeFrame: Approximately 9 hours after last dose
measure: Excessive Speed Count
timeFrame: Approximately 9 hours after last dose
measure: Average Speed and Speed Deviation
timeFrame: Approximately 9 hours after last dose
measure: Driving safety measures: Total number of excessive Ay (cornering speed threshold-exceeded)
timeFrame: Approximately 9 hours after last dose
measure: Driving safety measures: Total number of collisions
timeFrame: Approximately 9 hours after last dose
measure: Divided Attention: Correct responses; Omission Errors; Commission Errors; Reaction Time; Standard Deviation of Reaction Time
timeFrame: Approximately 9 hours after last dose
measure: CogScreen Symbol Digit Coding Test: Number of Correct responses
timeFrame: Approximately 9 hours after last dose
measure: CogScreen Symbol Digit Coding Test: Response Accuracy (percentage of correct responses)
timeFrame: Approximately 9 hours after last dose
measure: CogScreen Symbol Digit Coding Test: Standard Deviation of Reaction Time
timeFrame: Approximately 9 hours after last dose
measure: Karolinska Sleepiness Scale (KSS) Score
timeFrame: Approximately 9 hours after last dose
measure: Participant's self-reported Readiness to Drive
timeFrame: Approximately 9 hours after last dose
measure: Self-report of motivation and appraisal of driving performance using VAS
timeFrame: Approximately 9 hours after last dose
Other outcomes:
Locations:
city: Mount-Royal
country: Canada
facility: AltaSciences
Study officials:
References: