Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to evaluate the effect of a high-fat meal on the Pharmacokinetics of the Selective MET kinase Inhibitor DO-2 in subjects in good health

This study is designed to understand how your body reacts to a new medicine called DO-2 after you've eaten a high-fat meal. Researchers want to see if having a fatty meal changes how the medicine is absorbed, processed, and removed from your system. This kind of research helps scientists understand the best way for people to take new medicines in the future. It's a very early stage of testing, known as Phase I, and is looking for healthy adult volunteers to take part. The main goal is to gather important information about DO-2's journey through the body under specific conditions.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

DeuterOncology

Enrolment target

Start

25 Nov 2024

Healthy volunteer

What is this study about?

This research study is about a new medicine called DO-2. The main aim is to understand how your body handles this medicine when you've just eaten a meal that's high in fat. Think of it like this: when you take a tablet, your body needs to absorb it, use it, and then get rid of it. This process can sometimes be affected by what you eat. So, researchers want to see if a fatty meal changes how much DO-2 your body absorbs, how quickly it gets into your bloodstream, and how long it stays in your system.

This is a very early stage of testing for DO-2, often called Phase I. Studies like this are crucial because they help scientists learn important details about new medicines in healthy people, before they are tested in people who are unwell. The information gathered here will help doctors and researchers understand the best way for people to take DO-2 in the future, for example, whether it should be taken with food or on an empty stomach.

By taking part, you would be helping medical science gather vital information about this potential new medicine. It’s a chance to contribute to the safe and effective development of future treatments.

Key takeaways

This study helps understand how a new medicine, DO-2, works in the body.
It specifically looks at the effect of a high-fat meal on the medicine.
Healthy adult volunteers, aged 18 and over, are needed.
Participation involves clinic visits, blood tests, and taking the study medicine.
Your involvement helps advance medical research for future treatments.

Who may be eligible?

This study is looking for healthy adult volunteers. This means you should generally be in good health and not have any serious medical conditions that might affect how your body handles the study medicine.

You need to be at least 18 years old to take part. There's no upper age limit, so adults of all ages who are otherwise healthy can be considered. Both men and women are welcome to participate in this study.

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?
Do you have any serious ongoing medical conditions?
Are you able to attend appointments at a clinic?
Are you willing to have blood tests during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would typically visit a clinic or research centre. During your visits, you'll likely have some health checks, such as blood tests or heart readings, to make sure you're healthy enough for the study. You will be given the study medicine, DO-2, after you have eaten a special high-fat meal. Researchers will then regularly take blood samples to see how the medicine is moving through your body over time.

The study will involve several visits to the clinic, and you might need to stay there for a period of time during certain treatment days. The doctors and nurses will monitor you closely. There will also be follow-up appointments to check on your health after your last dose of the medicine. The total length of your participation would be explained fully before you join.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You won't directly benefit from this study, but you'll be helping scientists learn more about a new medicine, which could help others in the future. Potential risks might include discomfort from blood tests, or possible side effects from the study medicine, although these will be carefully monitored. You will be given clear information about any known risks before you agree to take part. Remember, you can choose to leave 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
Netherlands

Common questions

What is DO-2?

DO-2 is a new medicine being studied. This research focuses on how your body handles it.

Why do I need to eat a high-fat meal?

Researchers want to see if having a fatty meal changes how your body absorbs and processes the medicine, which is important for understanding how people might take it.

Who can join this study?

Healthy adults aged 18 and over, both men and women, are invited to take part.

Will I get sick from the medicine?

All medicines have potential side effects. You will be closely monitored, and any known risks will be explained in detail before you decide to join.

How long will I be involved?

The team will tell you the exact time commitment, including visits and follow-up, before you start.