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A study to compare how asundexian is absorbed in healthy adults using different formulations and the effect of food for the prevention of blood clots.

Investigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to investigate how the body processes the drug asundexian. The research focuses on the prevention of thromboembolic events, which refers to conditions where blood clots form inappropriately in the blood vessels. The study compares two different versions of the medication: a pediatric formulation, which is a version designed for children, and an adult formulation in the form of a tablet. Participants will take a single oral dose of either the granules or the tablet.

During the study, the way the body absorbs and uses the medication is monitored under different conditions. This involves looking at the pharmacokinetics, which is the study of how a substance moves through the body over time. One part of the study examines the medication when taken in a fasted state, meaning without any food in the stomach. Another part examines the effects of a high-fat, high-calorie meal on how the drug is absorbed by the body.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of the medication in a fasted state
A single dose of 50 mg of asundexian is taken using the pediatric formulation, which is provided as granules (small grains of medicine) for oral use.
This step is performed in a fasted state, meaning no food is consumed for a period before taking the medicine.
Step 2
Administration of the medication in an adult formulation
A single dose of 50 mg of asundexian is taken using the adult formulation, which is provided as a film-coated tablet for oral use.
This step is also performed in a fasted state.
Step 3
Assessment of food effects
A single dose of 50 mg of asundexian is taken using the pediatric formulation (granules) after consuming a high-fat, high-calorie meal.
This step is performed to observe how food affects the amount of medicine in the blood.

Who can join the trial?

5 criteria

You must be between 18 and 55 years old at the time you sign the agreement to join the study.
You must be considered generally healthy, which means a doctor will check your medical history, perform a physical exam, run blood or urine tests (laboratory tests), check your heart rhythm using a machine (ECG), and measure your vital signs, such as blood pressure and heart rate.
Your Body Mass Index (BMI), which is a calculation used to determine if your weight is healthy for your height, must be between 18 and 29.9.
The study is open to both men and women.
You or your partner must use contraception (methods to prevent pregnancy, such as birth control) in a way that follows local rules for people taking part in clinical studies.

Who cannot join the trial?

14 criteria

Having any existing health conditions that might change how the body absorbs, moves, breaks down, or removes the study medicine.
Eating or drinking foods containing grapefruit, pomelo, tangelo, or Seville oranges within 2 weeks before the first dose.
Drinking beverages that contain quinine, such as tonic water, within 2 weeks before the first dose.
Having specific heart rhythm issues found during an ECG (an electrical test of the heart), such as second-degree or third-degree AV block (problems with the electrical signals that tell the heart to beat), or if the time it takes for the heart to reset its electrical charge (the QRS complex or QTc interval) is longer than the normal range.
Having a systolic blood pressure (the top number in a blood pressure reading) that is lower than 90 mmHg or higher than 140 mmHg.
Having a diastolic blood pressure (the bottom number in a blood pressure reading) that is lower than 60 mmHg or higher than 90 mmHg.
Having a known hypersensitivity (an extreme allergic reaction) or intolerance to any of the active ingredients or inactive ingredients used in the study medicine or other medications used during the study.
Having severe allergies, such as being allergic to more than three different things, having allergic asthma (breathing difficulties caused by allergies), needing corticosteroids (medicines used to reduce swelling and inflammation) for allergies, having urticaria (hives), or having significant reactions to medicines that are not caused by allergies.
Having a febrile illness (an illness involving a fever) within 4 weeks before the study begins.
Having known coagulation disorders, which are conditions that prevent the blood from clotting properly, such as von Willebrand’s disease or hemophilia.
Having any known conditions that increase the risk of bleeding, such as periodontosis (gum disease), hemorrhoids (swollen veins in the rectum), acute gastritis (sudden inflammation of the stomach lining), or a peptic ulcer (a sore in the lining of the stomach or intestine).
Having a known tendency to bleed easily, such as frequent nosebleeds or very heavy menstrual periods.
Having known or suspected liver disorders, such as Morbus Gilbert (a common, harmless liver condition), or problems with bile secretion or flow, known as cholestasis.
Using any prescription drugs, over-the-counter medicines, supplements (like high-dose vitamins or carnitine), or herbal products (such as St. John’s wort) within 14 days before the study, unless the medicine is for contraception (preventing pregnancy) or hormonal replacement therapy.

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Investigated drugs

Asundexian is an experimental medicine being tested to see how it is absorbed and processed by the body when taken by mouth. This study compares how different forms of the medication, such as granules and tablets, behave in the body and how eating a high-calorie meal might change its effects.

Asundexian

What is already known about the treatment

Asundexian - This medication is taken by mouth in the form of granules or tablets to help prevent dangerous blood clots. It is currently being studied in clinical trials to better understand how it works in different age groups and with food. This drug belongs to a class of medicines called anticoagulants, which work by blocking a specific protein in the blood that helps clots form. By stopping this process at a molecular level, the medicine helps keep blood flowing smoothly through the body.

Investigated diseases

Thromboembolism - This condition occurs when a blood clot forms within a blood vessel and obstructs the flow of blood. It can develop in either arteries or veins throughout the body. The process typically begins with damage to the vessel wall or changes in blood flow and composition. Once a clot forms, it may stay in its original location or break loose and travel through the bloodstream. If the clot moves, it can lodge in smaller vessels in different parts of the body.