NCT05481528

A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy Participants

Completed Phase 1 Last updated 9 May 2023

What this trial tests

Phase 1 trial testing Moxifloxacin in Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men in 51 participants. Completed in 28 April 2023.

Timeline

19 August 2022

Primary endpoint
7 February 2023

28 April 2023

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	basic science
Enrollment	51
Start date	19 August 2022
Primary completion	7 February 2023
Estimated completion	28 April 2023
Sites	1 location across Germany

Drugs / interventions tested

• Moxifloxacin (moxifloxacin) — full drug profile →
• Elinzanetant (BAY3427080) — full drug profile →
• Placebo

Conditions studied

• Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men — all drugs for Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men →
• Hot Flashes — all drugs for Hot Flashes →
• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 55, any sex, with Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men or Hot Flashes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Researchers are looking for a better way to treat vasomotor symptoms, a condition of having hot flashes. The condition is caused by hormonal changes and occurs primarily in women, but can also affect men.

The study treatment, elinzanetant, is under development to treat symptoms caused by hormonal changes. It works by blocking a substance called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes.

Participants of this study will be healthy and will have no benefit from administration of elinzanetant. This study, however, will provide information on how to use it in people with vasomotor symptoms.

In previous studies, elinzanetant doses tested and resulting blood levels were close to the levels intended for treatment. However, in future use, it cannot always be ruled out that higher elinzanetant concentrations may occur in the blood if patients are taking certain other drugs at the same time, or take more than the recommended dose of the drug.

The main purpose of this study is to learn how safe elinzanetant is when higher doses than normally used are given compared to placebo in healthy participants. A placebo is a treatment that looks like a medicine but does not have any medicine in it.

To answer this, researchers will compare the number of participants who have medical problems after taking elinzanetant to those treated with placebo. Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.

The study consists of two parts. In part 1, the participants will either take a single dose of elinzanetant or placebo by mouth dependent on the treatment group. Four different increasing doses of elinzanetant will be tested.

Participants in dose group 1 and 4 will participate in part 2. About 8 days after treatment in part 1, the participants will receive a single dose of moxifloxacin and a single dose of placebo as tablet by mouth 5 days apart. Whether the participant starts with moxifloxacin or placebo is decided by chance. Moxifloxacin is used to make sure that certain changes in heart rhythm can be detected in the study.

Each participant will be in the study for about 6 weeks including 1 treatment day (part 1) or for about 8 weeks including 3 treatment days (part 1 \& 2). Participants of part 1 will stay in-house for 7 days. Participants of part 2 will stay in-house for another 9 days. The in-house phase starts two days before intake of the study treatment. In addition, one visit before and one visit after the in-house phase to the study site is planned.

During the study, the study team will:

* Do physical examinations
* Check vital signs
* Take blood and urine samples
* Examine the participants' heart health using electrocardiogram (ECG)
* Ask the participants questions about their mood and about sleepiness.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.