Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Single-Dose Two-Period Crossover Study to Assess the Effect of Food on MK-5684 Pharmacokinetics and to Monitor Pharmacodynamic Effects Over Time in Healthy Participants

This research study is designed for healthy male volunteers. Its main goal is to understand how a new medicine, called MK-5684, is absorbed and processed by the body when taken as a single dose. Researchers want to see if eating food at the same time changes how the medicine works, and how much of it reaches the bloodstream. They will also measure changes in important hormone levels, like testosterone, over a period of time. This is a very early stage (Phase I) study, meaning it's focused on safety and how the drug works in the body, rather than treating an illness. The insights gained from this study will help scientists decide if MK-5684 is suitable for further testing in patients with advanced prostate cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

25 Jul 2023

refractory metastatic prostate cancer

What is this study about?

This study is a very early step in developing a new medicine called MK-5684. It's known as a 'Phase I' study, which means the main focus is on understanding how the drug works in the body and its safety, rather than treating a disease. For this particular study, healthy male volunteers will receive a single dose of MK-5684. The researchers want to carefully observe what happens to the medicine after it's taken – for example, how much of it gets into the bloodstream and how long it stays there.

A key part of this study is to see if food affects how MK-5684 is absorbed. Participants will take the medicine either with food or without it, and researchers will compare the results. They will also be looking at how the medicine might change certain hormone levels in the body over time. This information is really important because it helps scientists work out the best way to give the medicine in future studies and helps them understand how it might affect the body.

While this study involves healthy people, the medicine itself is being developed for men with advanced prostate cancer that hasn't responded to other treatments. The information gathered here will be crucial for the next steps in developing MK-5684, ensuring it's used as effectively and safely as possible when it eventually reaches patients who need it.

Key takeaways

This is an early-stage study for a new prostate cancer medicine.
It involves healthy male volunteers, not cancer patients.
The main goal is to understand how the medicine is absorbed and processed by the body.
It will check if food affects how the medicine works.
Researchers will also monitor the medicine's effect on hormone levels.

Who may be eligible?

This study is specifically looking for healthy male volunteers. You must be at least 18 years old to take part; there is no upper age limit mentioned, as long as you are healthy enough for the study.

Because this is an early study to understand how a new medicine works in the body, it's very important that participants are generally in good health. This helps researchers see the effects of the study medicine clearly, without other health conditions making things complicated.

The study will likely have other health checks or requirements that aren't listed here. These would usually involve reviewing your medical history, having certain blood tests, and a physical examination to make sure you are suitable and that 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 male?
Are you at least 18 years old?
Are you generally in good health?
Are you willing to follow study instructions, including diet if required?
Are you able to attend all required clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given a single dose of the study medicine, MK-5684. You'll participate in two different periods: one where you take the medicine with food, and another where you take it without food. There will be a 'washout' period in between these, where you don't take the medicine, to make sure its effects have left your body before the next dose.

Throughout the study, you will have regular blood tests to measure how much of the medicine is in your body and how it's affecting your hormone levels. You'll also be monitored for any side effects or changes in your health. The total duration of your participation, including all visits and follow-ups, will be clearly explained to you by the study team. You'll typically need to attend several visits at the research clinic.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as contributing to medical knowledge that could help men with prostate cancer in the future. However, for healthy volunteers, there is no direct personal health benefit from receiving the study drug. Potential risks include experiencing side effects from the study medication, discomfort from blood draws, or allergic reactions. The research team will monitor you closely for any adverse events. You are free 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 MK-5684?

MK-5684 is a new medicine being developed to treat advanced prostate cancer that has stopped responding to other treatments. This study is an early step to understand how it works in the body.

Why is this study being done on healthy people if it's for cancer patients?

Early-stage studies like this often involve healthy volunteers first. This helps researchers safely learn how the medicine behaves in the body and what dose might be suitable, before testing it in patients who are unwell.

Will I receive treatment for cancer in this study?

No, this study is not a cancer treatment. It involves healthy volunteers and is designed to understand how the new medicine MK-5684 is processed by the body and its early effects on hormones.

What does 'pharmacokinetics' mean?

Pharmacokinetics is a scientific term that describes what the body does to a medicine – how it's absorbed, distributed, processed, and removed. This study will precisely measure these things for MK-5684.

What does 'pharmacodynamic effects' mean?

Pharmacodynamic effects refer to what the medicine does to the body. In this study, it means looking at how MK-5684 affects hormone levels over time.