Study on How Elinzanetant Affects Dabigatran Etexilate in Healthy Volunteers with Vasomotor Symptoms

1 1 1 1

What is this study about?

This clinical trial is focused on understanding how the study drug elinzanetant (also known by its code name BAY 3427080) affects the way another drug, dabigatran etexilate, moves into, through, and out of the body. The study involves healthy male and female participants. Elinzanetant is being studied for its potential effects on vasomotor symptoms, which are symptoms like hot flashes that can occur due to changes in hormone levels in both women and men.

The purpose of the study is to investigate the effect of a single dose of elinzanetant on the exposure of dabigatran etexilate in the body. Participants will receive a single dose of elinzanetant and then the movement of dabigatran etexilate in their bodies will be monitored. The study will help researchers understand how these two drugs interact when taken together.

During the study, participants will be monitored for any side effects or adverse events that may occur. The study aims to ensure the safety of participants while gathering important information about how these drugs work together. This research is important for developing better treatments for managing symptoms related to hormone changes.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, a medical evaluation will be conducted to confirm your health status. This includes reviewing your medical history, conducting a physical examination, checking your blood pressure and pulse rate, performing a 12-lead electrocardiogram (ECG), and conducting laboratory tests.

Your body weight and body mass index (BMI) will be measured to ensure they meet the study requirements. You must weigh at least 50 kg, and your BMI should be between 18.0 and 30.0 kg/m².

2 medication administration

You will receive a single oral dose of the study drug elinzanetant (also known as BAY 3427080). This medication is provided in the form of a soft capsule.

Following this, you will be given dabigatran etexilate, which is provided as a hard capsule under the name Pradaxa 75 mg. The purpose is to observe how elinzanetant affects the way dabigatran moves through your body.

3 monitoring and observation

After taking the medications, you will be monitored to assess how your body processes the drugs. This involves measuring the maximum concentration (Cmax) and the area under the curve (AUC) of dabigatran in your system.

You will be observed for any treatment-emergent adverse events (TEAEs), which are any side effects that may occur after taking the medication.

4 follow-up

A follow-up visit will be scheduled to review your health status and any effects experienced during the trial. This ensures your safety and well-being throughout the study.

Who Can Join the Study?

Participant must be between 18 and 65 years old at the time of signing the consent form.
Participants should be overtly healthy, meaning they should not have any noticeable health issues. This will be determined by a medical check-up, which includes reviewing medical history, a physical exam, checking blood pressure, pulse rate, a heart test called a 12-lead electrocardiogram (ECG), and laboratory tests.
Participants must weigh at least 50 kg (about 110 pounds) and have a body mass index (BMI) between 18.0 and 30.0. BMI is a measure that uses height and weight to estimate body fat.
Both males and females can participate.
Participants must use birth control methods that comply with local regulations if they are sexually active. This applies to both men and women.

Who Cannot Join the Study?

Participants must not have any serious health conditions that could interfere with the study.
Participants should not be taking any medications that might affect the study results.
Participants must not have a history of allergic reactions to the study medication.
Participants should not be pregnant or breastfeeding.
Participants must not have participated in another clinical trial recently.
Participants should not have any substance abuse issues.
Participants must not have any mental health conditions that could affect their ability to participate.
Participants should not have any significant liver or kidney problems.
Participants must not have any blood disorders.
Participants should not have any heart conditions that could interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Cux Cdxqdqqj Rnacrsbi Svhsnxqa Mniqvllfhf Gyjg	Wuppertal	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	10.08.2022

Trial locations

Investigated drugs:

Elinzanetant is a medication being studied to see how it affects the way another drug is processed in the body. In this trial, participants receive a single dose of elinzanetant to understand its impact on the levels of another medication in the bloodstream. This helps researchers learn more about how elinzanetant might interact with other drugs.

Dabigatran Etexilate is a medication that is usually used to prevent blood clots. In this study, it is given to participants to see how its levels in the blood are affected when taken with elinzanetant. By understanding this interaction, researchers can ensure that dabigatran etexilate is used safely and effectively when combined with other medications.

Investigated diseases:

Vasomotor Symptoms – Vasomotor symptoms are characterized by episodes of flushing and sweating, often referred to as hot flashes or night sweats. These symptoms are commonly associated with hormonal changes, particularly during menopause in women, but can also occur in men. The episodes can vary in frequency and intensity, often leading to discomfort and disruption of daily activities. The underlying cause is believed to be related to changes in the body’s temperature regulation due to fluctuating hormone levels. These symptoms can persist for varying durations, sometimes lasting for several years. They are a common aspect of the natural aging process in both women and men.

Trial ID:

2022-500201-41-00

Protocol code:

22081

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider