Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

MK-1403 Single Dose Formulation PK Study

This research study is about a new medicine, MK-1403, and how it works in the body. The study is for a condition called atherosclerosis, which affects your arteries (blood vessels). This is an early phase of testing a new medicine, sometimes called a Phase 1 study. Its main aim is to understand how your body handles a single dose of MK-1403, specifically how it's absorbed, how long it stays in your system, and how your body gets rid of it. This helps scientists decide if it's safe to continue testing the medicine in larger groups of people. Participants will be healthy adult men.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

06 Nov 2023

Atherosclerosis

What is this study about?

This study is a very early stage of testing for a new medicine, called MK-1403. Think of it like taking a brand new car for a very careful first test drive to see how it performs. The medicine is designed to help with a condition called atherosclerosis. This is when fatty deposits, called plaques, build up inside your arteries. Arteries are like pipes that carry blood around your body, so blockages can be very serious and lead to heart attacks or strokes.

In this study, researchers want to see exactly what happens when healthy volunteers take a single dose of MK-1403. They are particularly interested in how the medicine gets into the bloodstream, how long it stays there, and how the body eventually removes it. This information is called "pharmacokinetics" and it's really important for understanding how a new medicine works.

By gathering this detailed information, scientists can learn more about MK-1403. This early research helps them decide on the right dose for future studies and whether the medicine is promising enough to be tested in more people who have atherosclerosis. It's a crucial step in developing new treatments.

Key takeaways

This is an early-stage study for a new medicine called MK-1403.
It aims to understand how a single dose of the medicine works in healthy men.
The medicine is being developed for atherosclerosis, a condition affecting arteries.
Participants will have blood samples taken to track the medicine.
No long-term treatment, only a single dose is given.
Your participation helps advance medical research for future treatments.

Who may be eligible?

To take part in this study, you must be an adult man, aged 18 years or older. There is no upper age limit, meaning older men are also welcome to participate as long as they meet other health criteria.

Because this is an early study to understand how a new medicine behaves in the body, participants must be generally healthy. The full details of what 'healthy' means will be explained by the study team, but it typically involves not having any major ongoing illnesses or taking certain regular medications.

Only men are invited to join this particular study. This is common in early-stage research to simplify the initial findings, as some medicines can behave differently in men and women.

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 18 years old or older?
Are you male?
Are you generally healthy?
Are you able to attend clinic visits as required?
Are you able to understand and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single dose of the study medicine, MK-1403. This is not a long-term treatment study. You would have several visits to the study clinic, likely over a short period. During these visits, the study team would take blood samples at specific times to measure how much of the medicine is in your body and how long it stays there. You might also have other checks, like your blood pressure and heart rate, to make sure you are well. The exact number of visits and the total time you'd spend in the study will be explained in full by the study team.

Potential risks and benefits

Potential benefits of participating include contributing valuable information that could help develop new treatments for atherosclerosis in the future. However, there's no direct personal health benefit expected from taking a single dose of this experimental medicine. Potential risks might include side effects from the medicine itself, even though it's an early-stage study designed for healthy individuals. There are also discomforts associated with procedures like blood draws. You 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 when fatty materials build up inside your arteries, making them narrow and hard. This can reduce blood flow and cause serious health problems.

Why is this study only for men?

Early studies sometimes focus on one gender to make it simpler to understand how a new medicine works in the body before testing it more widely.

Will I be given the atherosclerosis medicine for a long time?

No, you will only receive a single dose of the medicine, MK-1403, in this particular study. It's not designed as a treatment trial.

Will I get paid for taking part?

Some studies offer payment for your time and travel, but this is something you should discuss directly with the study team.

What does a 'Human Pharmacology (Phase I)' study mean?

This is a very early stage of testing a new medicine in people. The main goal is to see how the body handles the medicine and check for any immediate safety concerns.