Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Imatinib PD in healthy subjects

This study is an early-stage research project designed to understand how a drug called imatinib affects the human body. We're inviting healthy volunteers to take part, meaning people who don't have any specific medical conditions that might affect the study. The main goal is to learn more about how the drug works and what it does in the body. This kind of study helps scientists gather important information about new medicines before they are tested in people who are unwell. It's not about treating an illness, but about carefully observing the drug's effects to ensure we understand it better for future research and development.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Centre for Human Drug Research

Enrolment target

Start

08 Dec 2023

Immuno-oncology assessments

What is this study about?

This research study is called 'Imatinib PD in healthy subjects'. It's focused on understanding how a medicine called imatinib works in the body of people who are healthy. This type of study is often the first step when a new medicine is being developed, or when we want to learn more about an existing one.

The main purpose here isn't to treat an illness, but to carefully observe how the drug behaves once someone has taken it. This includes looking at things like how the body absorbs, distributes, and gets rid of the medicine, and what effects it might have. Researchers want to gather as much information as possible in a controlled way.

Studies like this are really important because they help us build a strong foundation of knowledge about a drug. The information learned from healthy volunteers can help doctors and scientists understand how to use the medicine safely and effectively in the future, especially if it's considered for people with certain health conditions. It's all about making sure medicines are well understood before they are used more widely.

Key takeaways

This study is looking at how a medicine called imatinib works.
It involves healthy adults (18 years and older) of all genders.
The goal is to understand the drug's effects, not to treat illness.
Participation helps future medical research and understanding of medicines.
You can stop participating at any time if you change your mind.

Who may be eligible?

To be able to join this study, you need to be at least 18 years old. There's no upper age limit mentioned, so older adults could also be considered.

Both men and women are welcome to take part in this research. The study isn't limited by gender.

The most important thing is that you need to be generally healthy. This means you shouldn't have any serious ongoing medical conditions that might affect how the medicine works in your body or make it unsafe for you to participate.

Quick self-check

Are you 18 years old or older?
Are you generally healthy?
Do you have any significant ongoing medical conditions?
Are you comfortable potentially having blood tests and other check-ups?
Do you understand this is a research study, not a treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would likely need to visit the study clinic several times. During these visits, you might have blood samples taken, or other checks to see how the medicine is affecting your body. You would receive the study medicine, imatinib, according to a specific plan set out by the researchers.

It's possible there could be follow-up appointments after you've taken the medicine, to make sure everything is okay and to gather final information. The total length of your involvement in the study, from your first visit to your last, would be explained to you before you agree to take part. All procedures would be explained clearly, and your safety would be a priority.

Potential risks and benefits

Participating in this study might offer a small personal benefit of a thorough health check-up during screening. More broadly, you'd be contributing to valuable medical research that helps others. However, there are potential risks, as with any medicine. You might experience side effects from the drug, which will be explained in detail. You would have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Netherlands

Common questions

What is imatinib?

Imatinib is a type of medicine that affects certain processes in the body. In this study, we are observing how it works in healthy people, not treating any specific illness.

Why are healthy people needed for research?

Healthy volunteers help researchers understand how a medicine works in a 'normal' body without the effects of an illness, which is a crucial first step in drug development.

What kind of tests will I have?

You might have blood tests and other routine health checks to monitor how the medicine affects your body. All tests will be fully explained to you.

Will I be paid to take part?

While this information isn't provided here, many studies involving healthy volunteers offer compensation for time and travel. You should ask the study team about this.

Can I leave the study if I change my mind?

Yes, you are always free to withdraw from the study at any point, for any reason, without having to explain why, and it won't affect your medical care.