Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

MK-1084 Single and Multiple Dose Healthy Participant Study

This study is a very early step in testing a new drug named MK-1084. It's designed for healthy people, not those with an illness, to find out if the drug is safe and how the body processes it. During the study, participants will be given different amounts of MK-1084 once or multiple times. The main goal is to understand how the drug behaves in the human body, such as how long it stays in the system and if it causes any unwanted effects. This vital initial information helps researchers decide if MK-1084 has the potential to be developed further as a treatment for conditions like solid tumours and lung cancer in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

25 Oct 2023

Solid tumor cancer and lung cancer

What is this study about?

This study is an early stage of research, sometimes called 'Phase 1', into a new medicine known as MK-1084. At this stage, the main goal is to understand how safe the new drug is and how the body reacts to it. It’s a bit like learning about a new car engine – you want to know how it runs and if it has any quirks before putting it into a full car and taking it on the road.

Because we're still learning about MK-1084, this study involves healthy volunteers. This means people who don't have a specific illness will take part. This helps researchers see how the drug works in a body without any other health conditions influencing the results. They will give different people different amounts of the drug, sometimes just once, and sometimes over several days. This helps them understand what doses are safe and how the body deals with the drug.

The information gathered from this study is really important. It helps scientists decide if MK-1084 has the potential to become a treatment for certain types of cancer, like solid tumours and lung cancer, in the future. It's a crucial first step before the drug can be tested in people who actually have these conditions.

Key takeaways

This is a very early study of a new medicine called MK-1084.
It aims to check the safety of the drug and how the body handles it.
Only healthy adults aged 18 and over can participate.
The study helps pave the way for potential future cancer treatments.
Participants contribute to important medical research.
You can stop participating at any time.

Who may be eligible?

To join this study,您 must be an adult aged 18 or older. Both men and women are welcome to take part.

Because this is a very early study looking at how a new drug works in the human body, it's designed for people who are generally healthy. This means that if you have certain existing health conditions, you might not be able to participate. The study team will need to check your medical history carefully to make sure.

The doctors and nurses involved will carry out a thorough health check to ensure it's safe for you to take part. They will explain all the specific requirements in detail and answer any questions you have.

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 generally in good health?
Are you willing to attend regular clinic visits?
Are you comfortable having blood and urine samples taken?
Do you understand this is a research study and not a treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new medicine, MK-1084, either as a single dose or multiple doses over a period of time. You would have regular visits to the clinic or hospital, where the study team would check your health, take blood and urine samples, and monitor you closely for any changes or side effects. This monitoring helps them understand how your body is reacting to the medicine.

The total duration of your involvement in the study, including all visits and follow-up checks, would be explained to you in detail by the study team. They will tell you how many visits are needed, how long each visit might be, and the total length of your participation.

Potential risks and benefits

Taking part in any medical study has both potential benefits and potential risks. A potential benefit of this study is contributing to medical research that could one day lead to new treatments for serious illnesses like cancer. However, as this is an early-stage study, there's no direct personal health benefit for you as a participant. You might experience side effects from the new medicine, which could be mild or, in rare cases, more serious. All known risks will be clearly explained to you by the study team. 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.

—
Unverified
Belgium

Common questions

What is MK-1084?

MK-1084 is a new medicine being tested. It's being developed as a possible future treatment for certain cancers, but this study is just the first step to understand it.

Why is this study for healthy people?

Because it's a very early study, testing it in healthy people helps researchers safely learn how the drug works in the body without other health conditions affecting the results.

Will I get better if I join this study?

No, this study is not designed to treat an illness. It's about learning how a new drug works, not providing a health benefit to participants.

What will happen if I take part?

You'll be given the study medicine, and doctors will monitor your health closely through visits, blood tests, and checks for any side effects.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, for any reason, and this won't affect your medical care.