A study comparing blood levels of finerenone when taken as one 40 mg tablet versus two 20 mg tablets in healthy male participants

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What is this study about?

This study is looking at heart failure with left ventricular ejection fraction ≥40%, which is a condition where the heart does not pump blood as well as it should, but still maintains a certain level of pumping ability. The treatment being studied is finerenone, also known by its code name BAY 94-8862, which is given as a film-coated tablet that is taken by mouth. The purpose of this study is to compare how much of finerenone gets into the blood when the same total amount is taken either as one 40 mg tablet or as two 20 mg tablets.

This is a study in healthy male adult participants to understand if taking the medication in different tablet forms results in the same amount of the drug in the body. The study follows a crossover design, which means that each participant will receive both forms of the medication at different times, allowing researchers to compare the results within the same person. The study is not blinded, meaning both the participants and the researchers will know which form of the tablet is being given at any time.

During the study, participants will take the medication and blood samples will be collected to measure the amount of finerenone in the blood over time. The researchers will look at the highest level of the drug reached in the blood and the total amount of drug that enters the blood over a period of time. The study will also monitor any unwanted effects that may occur during treatment to ensure the safety of the participants.

1 First treatment period

You will receive finerenone in one of two dosing forms. The study treatment is taken by mouth.

You will either take one tablet of 40 mg or two tablets of 20 mg. Both options provide the same total amount of the study treatment.

Blood samples will be collected to measure how much finerenone is present in your blood over time. This helps determine the maximum concentration (the highest level of the treatment in your blood) and the total amount absorbed by your body.

2 Washout period

After the first treatment period, there will be a break before the next treatment period.

During this time, you will not receive any study treatment. This allows the finerenone from the first period to be completely eliminated from your body.

3 Second treatment period

You will receive the alternate dosing form of finerenone that you did not take in the first treatment period.

If you took one tablet of 40 mg in the first period, you will now take two tablets of 20 mg. If you took two tablets of 20 mg in the first period, you will now take one tablet of 40 mg.

Blood samples will again be collected to measure finerenone levels in your blood, using the same methods as in the first treatment period.

4 Safety monitoring

Throughout the study, you will be monitored for any side effects or adverse events.

Medical evaluations will include physical examinations, laboratory tests, body temperature, vital signs (such as blood pressure and heart rate), and electrocardiogram (a test that records the electrical activity of your heart).

Any health changes or side effects that occur during the study will be recorded and assessed.

Who Can Join the Study?

You must be between 18 and 55 years old at the time you sign the consent form to join the study
You must be in good overall health, which will be checked through your medical history, a physical exam, blood and urine tests, body temperature measurement, checks of your heart rate and blood pressure, and a test that records the electrical activity of your heart called an ECG
Your BMI must be between 18.0 and 29.9. BMI stands for Body Mass Index, which is a number calculated from your weight and height that shows if your body weight is in a healthy range
If you are a man or a woman able to have children, you must use birth control methods that follow local rules for people taking part in medical studies

Who Cannot Join the Study?

Women cannot participate in this study
Left ventricular ejection fraction (a measurement of how well the heart pumps blood) below 40%
Heart failure that does not meet the specific study requirements
Age outside the specified range for adult participants
Any condition that would make participation unsafe or affect the study results
Use of medications that may interfere with the study drug
Severe kidney problems that affect how the body processes medications
Severe liver problems that affect how the body processes medications
Known allergy or sensitivity to finerenone (the study medication) or its ingredients
Participation in another clinical trial within a recent time period
Any medical condition that the study doctor determines makes participation inappropriate

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
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Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	05.05.2023

Trial locations

Investigated drugs:

Finerenone

Finerenone is a medication being tested in this study. The trial is comparing two different ways of taking the same total amount of this medicine: either as two tablets or as one tablet. This study is checking whether both ways of taking the medication work the same way in the body.

Investigated diseases:

Heart failure with reduced ejection fraction

Heart Failure with Preserved Ejection Fraction – This is a type of heart failure where the heart muscle becomes stiff and cannot relax properly between beats, even though it still squeezes normally. The left ventricle, which is the main pumping chamber of the heart, maintains its ability to pump blood out with each beat at 40% or more of its volume. However, the heart cannot fill with enough blood during the resting phase between beats. This leads to a backup of blood in the lungs and other parts of the body, causing symptoms like shortness of breath, fatigue, and swelling in the legs and ankles. The condition typically develops gradually over time as the heart muscle becomes increasingly stiff. It is more common in older adults and people with high blood pressure or diabetes.

Trial ID:

2022-502385-24-00

Protocol code:

22292

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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A study comparing blood levels of finerenone when taken as one 40 mg tablet versus two 20 mg tablets in healthy male participants

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?