NCT05471817

A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female Participants

Completed Phase 1 Last updated 22 November 2022

What this trial tests

Phase 1 trial testing Elinzanetant (BAY3427080) in Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men in 20 participants. Completed in 14 November 2022.

Timeline

5 August 2022

Primary endpoint
20 September 2022

14 November 2022

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	20
Start date	5 August 2022
Primary completion	20 September 2022
Estimated completion	14 November 2022
Sites	1 location across Germany

Drugs / interventions tested

• Elinzanetant (BAY3427080) — full drug profile →
• Dabigatran etexilate (DABIGATRAN) — full drug profile →

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 65, 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 men and women with vasomotor symptoms, a condition of having hot flashes caused by hormonal changes.

The study drug, 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 elinzanetant in people with vasomotor symptoms.

The main purpose of this study is to learn whether the study drug elinzanetant (BAY3427080) affects the way the substrate drug dabigatran moves into, through and out of the body.

One way of removing substances such as drugs from the body are proteins which act as transporters. One such transporter is called P-gp. As a so-called substrate of P-gp, dabigatran is typically removed from the body by P-gp transporters.

The activity of transporters can be increased by substances called inducers and decreased by substances called inhibitors. It has been found in laboratory experiments that the study drug elinzanetant is a weak inhibitor of the P-gp transporter. Inhibition of this transporter can lead to an increase in the amount of drugs such as dabigatran in the blood.

This study is therefore needed to make recommendations on how elinzanetant can be used safely together with other drugs that are removed from the body by the P-gp transporter.

To answer this, the researchers will compare

* the average highest level of dabigatran in the blood (also referred to as Cmax)
* the average total level of dabigatran in the blood (also referred to as AUC) when dabigatran is given alone and is given together with elinzanetant. All participants will take one dose of dabigatran by mouth in the first period of the study. And after 4 days, the participants will take one dose of elinzanetant by mouth and at 30 minutes later, one dose of dabigatran by mouth during the second period of the study. The total duration of individual study participation will be about 4.5 weeks including the screening period. Each participant will stay in the center for 9 days with 8 overnight stays.

During the study, the study team will:

* take blood and urine samples
* do physical examinations
* check the participants' overall health
* examine heart health using ECG
* check vital signs
* 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.

Publications & conference data

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