Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Single Ascending Dose Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1403 in Healthy Male Participants

This is an important early-stage medical study to check a new medicine, MK-1403, designed to help with atherosclerosis. Atherosclerosis is when your arteries get clogged, making it harder for blood to flow. This study is the very first time this new medicine is being given to humans, specifically healthy men. Our main goals are to make sure the medicine is safe, see if people can tolerate it well, and understand how the body absorbs, uses, and gets rid of it. We'll be carefully watching for any side effects and how healthy men react to different doses. This research is a crucial first step in developing potential new treatments for atherosclerosis.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

14 Jun 2023

Atherosclerosis

What is this study about?

This study is about a new medicine called MK-1403. Scientists are developing this medicine to potentially help people with a condition called atherosclerosis. You might know atherosclerosis as 'hardening of the arteries' or clogged arteries. It's a common condition where fatty substances, cholesterol, and other things build up in the walls of your arteries. Over time, this build-up can narrow your arteries, making it harder for blood to flow through them. This can lead to serious health problems like heart attacks and strokes.

Because this is a brand new medicine that has never been given to people before, the very first step is to make sure it's safe. That's why this study is called a 'Phase I' study. It's not about curing atherosclerosis yet, but about gathering vital information on how the human body reacts to the medicine. We need to find out if it causes any unwanted effects and how much of it the body takes in and gets rid of. This will help doctors decide if it's safe to continue testing the medicine in larger groups of people who actually have atherosclerosis.

By carefully studying this medicine in healthy volunteers first, researchers can learn important details about its safety and how it works in the body. This information is crucial for future research and helps ensure that any new treatments developed are as safe and effective as possible for patients who might need them.

Key takeaways

This is an early-stage study (Phase I) of a new medicine called MK-1403.
It aims to check the safety and how the body handles the medicine in healthy men.
The medicine is being developed for atherosclerosis, a condition affecting arteries.
Participants will receive a single dose and be closely monitored for side effects.
Your involvement helps medical science but doesn't offer direct health benefits to you.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for healthy men to take part. To be eligible, you need to be at least 18 years old. There isn't an upper age limit mentioned, but you'll need to be in good general health.

The study is specifically designed for male volunteers because it's the very first time this medicine is being tested in humans. Studies like this often start with a specific group to control variables and carefully monitor the initial reactions to a new drug.

If you're a male aged 18 or over and generally healthy, you might be suitable for this study. Doctors and nurses involved in the study will do a thorough health check to make sure it's safe for you to participate.

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.

Are you a man?
Are you 18 years old or older?
Are you generally in good health?
Are you able to attend clinic visits as required?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given a single dose of the new medicine, MK-1403. You'll also be given some inactive ingredients like microcrystalline cellulose and magnesium stearate, which are commonly found in tablets and help the medicine to be packaged and absorbed properly. You'll be closely monitored by medical staff for a period of time after taking the medicine.

During your time in the study, you'll have various medical assessments. These will likely include blood tests to measure how the medicine moves through your body and how long it stays there. You'll also have regular health checks to make sure you're feeling well and to look out for any side effects. The study team will explain exactly how many visits you'll need, how long each visit will be, and the total duration of your involvement in the study before you agree to take part.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For you as a participant, a direct health benefit from this particular study is unlikely as it's an early-stage safety study in healthy individuals. However, your participation will greatly help advance medical knowledge and could contribute to developing new treatments for atherosclerosis in the future. As for risks, because it's a new medicine, there's always a chance of unexpected side effects, some of which could be mild, like a headache, or potentially more serious. The study team will carefully explain all known and possible risks. You also have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is atherosclerosis?

Atherosclerosis is a condition where fatty materials, cholesterol, and other substances build up in your arteries, making them narrower and harder. It's sometimes called 'hardening of the arteries'.

Why is this study only for healthy men?

This is a very early study, the first time this medicine is given to humans. Such studies often start with a specific group, like healthy men, to carefully check safety and how the body handles the medicine before testing it more widely.

Will this medicine cure my atherosclerosis if I had it?

This study isn't designed to find a cure. It's a first step to see if the medicine is safe and how it behaves in the body. If it proves safe, it might lead to treatments for atherosclerosis in the future.

What are 'side effects'?

Side effects are any unwanted or unexpected reactions to a medicine. The study team will closely monitor you for any side effects while you are taking part.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, without needing to give an explanation. Your medical care will not be affected.