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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hot Flashes; Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
• Intervention / Treatment: Drug: Elinzanetant (BAY3427080); Drug: Placebo to elinzanetant; Drug: Zopiclone; Drug: Placebo to zopiclone

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Canada
  • Mount-Royal, Canada, H3P 3P1
    • Altasciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment sequences A-C-D-B; Treatment A (elinzanetant dose A). Treatment B (elinzanetant dose B). Treatment C (zopiclone 7.5 mg). Treatment D (placebo).	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
Experimental: Treatment sequences B-D-C-A; Treatment A (elinzanetant dose A). Treatment B (elinzanetant dose B). Treatment C (zopiclone 7.5 mg). Treatment D (placebo).	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
Experimental: Treatment sequences C-B-A-D; Treatment A (elinzanetant dose A). Treatment B (elinzanetant dose B). Treatment C (zopiclone 7.5 mg). Treatment D (placebo).	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
Experimental: Treatment sequences D-A-B-C; Treatment A (elinzanetant dose A). Treatment B (elinzanetant dose B). Treatment C (zopiclone 7.5 mg). Treatment D (placebo).).	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Simulated driving performance as measured by SDLP using CRCDS-MiniSim	SDLP: standard deviation of lateral position. CRCDS-MiniSim: Cognitive Research Corporation's Driving Simulator-MiniSim.	Approximately 9 hours after last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lane Exceedance: Number of Exceedance.		Approximately 9 hours after last dose
Lane Exceedance: Maximum Duration of Exceedance.		Approximately 9 hours after last dose
Lane Exceedance: Area of Exceedance.		Approximately 9 hours after last dose
Excessive Speed Count		Approximately 9 hours after last dose
Average Speed and Speed Deviation		Approximately 9 hours after last dose
Driving safety measures: Total number of excessive Ay (cornering speed threshold-exceeded)		Approximately 9 hours after last dose
Driving safety measures: Total number of collisions		Approximately 9 hours after last dose
Divided Attention: Correct responses; Omission Errors; Commission Errors; Reaction Time; Standard Deviation of Reaction Time		Approximately 9 hours after last dose
CogScreen Symbol Digit Coding Test: Number of Correct responses	CogScreen Symbol Digit Coding test is a computer analogue of the conventional digit symbol-substitution task found in the revised Wechsler intelligence scales.	Approximately 9 hours after last dose
CogScreen Symbol Digit Coding Test: Response Accuracy (percentage of correct responses)		Approximately 9 hours after last dose
CogScreen Symbol Digit Coding Test: Standard Deviation of Reaction Time		Approximately 9 hours after last dose
Karolinska Sleepiness Scale (KSS) Score	The KSS measures an individual's subjective level of sleepiness. Participants indicate their level of alertness versus sleepiness according to a 9-point scale, ranging from "extremely alert" to "extremely sleepy - fighting sleep".	Approximately 9 hours after last dose
Participant's self-reported Readiness to Drive	Prior to driving, the participant will be asked a simple question as to whether they feel safe to drive ("Right now do you feel safe to drive?"). Participant will answer "yes" or "no".	Approximately 9 hours after last dose
Self-report of motivation and appraisal of driving performance using VAS	Participants will record their response to each question by drawing a vertical line on a 100-mm horizontal, linear VAS printed on paper. For the self-assessment of driving performance, one end of the line is marked "Not Satisfactory" and the other end of the line is marked "Satisfactory". For the motivation item, 1 end of the line is marked "Not Motivated" and the other end is marked "Motivated". Scores on the 100-mm linear scale will be measured to the nearest millimeter from the left with a ruler.	Approximately 9 hours after last dose

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): April 10, 2024
• Study Completion (Estimated): April 10, 2024

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive function; Driving performance,
• Additional Relevant MeSH Terms: Hot Flashes; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives; Zopiclone
• Other Study ID Numbers: 22653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No