Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

MK-7480 Multiple Ascending Dose Study in Healthy Participants

This study, called MK-7480, is looking at a new medicine in healthy men. It's a Phase I trial, which means it's one of the first times this medicine is given to people. The main goals are to check if the medicine is safe at different dose levels and to understand how the body uses and gets rid of it. This information is really important for developing new treatments. The medicine is being developed with the hope of eventually helping people with a specific type of liver condition called non-alcoholic steatohepatitis, often shortened to NASH.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

02 Feb 2024

What is this study about?

This study is a very early stage trial, often called a 'Phase I' study. Think of it as the first step in testing a completely new medicine in humans. The medicine being tested is called MK-7480. Because it's so new, the main focus is on safety. Researchers want to understand how much of the medicine a person can take without serious side effects and how the body processes it.

While this specific study is for healthy men, the medicine, if proven safe and effective in later stages, is being developed to treat a liver condition called non-alcoholic steatohepatitis, or NASH. NASH is a type of fatty liver disease that can lead to serious liver damage if not managed. By conducting these early studies in healthy volunteers, scientists can gather important information that will inform future research into whether MK-7480 could become a helpful treatment for people with NASH.

This kind of research is vital for bringing new medicines to people who need them. It’s a careful and step-by-step process, starting with healthy volunteers to understand the basics of the new medicine before it’s tested in people with the condition.

Key takeaways

This is a Phase I study testing a new medicine, MK-7480.
The main goal is to check safety and how the body handles the medicine.
It's for healthy men, aged 18 and over.
The medicine is being developed for a liver condition called NASH.
Participation helps advance medical research for future treatments.

Who may be eligible?

To join this study, you need to be a man aged 18 years or older. There is no upper age limit for participants in this specific study.

Since this is a study for healthy volunteers, you will have to undergo medical checks to ensure you don't have any existing health problems that could affect the study's results or put you at risk. The research team will explain all the specific health requirements in detail.

Important note: This study is specifically for men. Women are not eligible to take part in this particular trial.

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 male?
Are you 18 years old or older?
Are you generally healthy?
Are you able to commit to several clinic visits?

Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves is not fully provided here. However, based on similar Phase I studies, here's what you can generally expect: You would likely have several visits to the study clinic, possibly including overnight stays, especially when receiving different doses of the medicine. During these visits, the research team would monitor your health carefully, including blood tests, urine tests, and checking your vital signs (like blood pressure and heart rate). The study involves taking the investigational medicine, MK-7480. There will also be follow-up appointments after you've finished taking the medicine to ensure you are well. The total duration of your participation would be explained fully by the study team.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. The potential benefit for you as a participant in a healthy volunteer study often involves access to detailed health checks and the satisfaction of contributing to medical science. However, there is always a risk that the experimental medicine might have unexpected side effects, some of which could be serious. The research team will explain all known potential risks in detail before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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 non-alcoholic steatohepatitis (NASH)?

NASH is a liver condition where there is inflammation and liver cell damage, along with fat in the liver. It's not caused by drinking too much alcohol.

Why are healthy people needed for trials like this?

Testing new medicines in healthy people first helps researchers understand how the medicine behaves in the body and if it's safe without the added complications of an existing illness.

Will I get paid for taking part?

Many healthy volunteer studies offer compensation for your time and travel, but specific details would be confirmed by the study site.

What does 'multiple ascending dose' mean?

It means participants will receive the medicine in several doses, starting low and gradually increasing, so researchers can see how the body reacts to different amounts.

What is a Phase I study?

It's the first stage of testing a new medicine in people, focusing mainly on safety, side effects, and how the medicine is processed by the body.