A clinical trial of MK-1824 in healthy participants (MK-1824-001)
This clinical trial is looking at a new medicine called MK-1824. It is a Phase 1 study, which means it is the very first time the drug is being tested in humans. Because of this, researchers are testing it in healthy male volunteers first, rather than people who are unwell. The main aim is to see how safe the drug is, what side effects it might cause, and how it moves through the body. Although healthy volunteers are taking part, the medicine is being developed to potentially treat a type of heart condition known as heart failure with preserved ejection fraction. In this condition, the heart pumps normally but becomes too stiff to fill with blood properly. Findings from this study will help doctors decide if MK-1824 is safe enough to test in people living with heart failure in the future.
At a glance
What is this study about?
This study is an early-stage clinical trial investigating an experimental medicine called MK-1824. Because this is a 'Phase 1' study, it is the first time doctors are giving the drug to people. Before any new medicine can be offered to patients who are ill, researchers must carefully test it in a small group of healthy people to ensure it is safe and to see how the human body reacts to it.
MK-1824 is being developed with the goal of treating a specific condition called heart failure with preserved ejection fraction. In a healthy heart, the muscle relaxes to fill with blood and then squeezes to pump it around the body. In this type of heart failure, the heart muscle becomes stiff. It can still pump well, but it cannot relax properly to fill with blood, leading to symptoms like tiredness, breathlessness, and swollen ankles. There are currently limited treatments available for this condition.
By testing MK-1824 in healthy volunteers, scientists can see how the medicine is absorbed, broken down, and cleared by the body without the results being confused by other medical problems. This gives researchers a clear picture of how the drug works and what dose might be safe and effective for future studies.
While this study will not treat any illness directly, the information gathered is an essential first step. If the results show that MK-1824 is safe and well tolerated, researchers can move on to larger trials involving patients who live with heart failure.
Key takeaways
- MK-1824 is an experimental medicine being tested in humans for the first time.
- The trial is open to healthy men aged 18 and over.
- The main purpose is to test safety and side effects, not to treat an existing illness.
- The drug is being developed to potentially treat a form of heart failure in the future.
- Participants will be closely monitored with heart tests and blood checks.
Who may be eligible?
This study is looking for healthy male volunteers aged 18 and older. Because this is the first time the medicine is being given to humans, the trial team needs participants who do not have major medical conditions, ensuring any reactions can be clearly linked to the medicine itself.
To be eligible, you must be in good general health. Men who take regular prescription medicines or who have long-term health issues—especially heart, kidney, or liver problems—are usually not able to join.
Before taking part, volunteers will attend a screening appointment. The medical team will check your medical history, perform a physical examination, and run routine tests such as blood tests, urine tests, and an electrocardiogram (ECG) to confirm that your heart is healthy.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am a man aged 18 or older.
- I am in good general health with no major illnesses.
- I do not have a history of serious heart, liver, or kidney problems.
- I am not currently taking regular prescription medications.
- I am willing and able to attend clinic visits and follow-up checks.
What does participation involve?
If you decide to take part, you will first attend a screening visit to check your general health. If you are eligible, you will be given the study drug, MK-1824, under close medical supervision. Depending on the exact study plan, you may need to stay overnight in a specialised clinic or attend several day visits. The trial team will closely monitor you by checking your blood pressure, heart rate, and heart rhythm using an ECG. They will also take regular blood and urine samples to see how your body breaks down the medicine. After receiving the dose, you will have follow-up checks over several days or weeks to ensure you feel well. The research team will explain the exact schedule and time commitment before you agree to join.
Potential risks and benefits
Locations (1)
- —UnverifiedBelgium
Common questions
Why is this trial only testing healthy men?
Early trials often start with healthy adult men to reduce potential risks and avoid factors like fluctuating hormone levels or interactions with other illnesses, keeping the initial safety test as clear as possible.
Will this medicine protect me from heart problems?
No. This trial is designed only to test how the body handles the drug and whether it causes side effects. It is not intended to provide any direct health protection.
Will I be paid for taking part?
Phase 1 trials involving healthy volunteers usually offer payments to cover travel, time, and inconvenience. The study team can provide full details about this.
What happens if I feel unwell during the trial?
Doctors and nurses will monitor you very closely in a clinic. If you feel unwell or experience side effects, medical staff will care for you right away.
Can I change my mind after signing up?
Yes. Taking part is entirely your choice. You are free to stop participating at any point, even after you have signed the consent form.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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