Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A trial to learn how much [11C]savolitinib enters the brains of healthy participants

This study is about a medicine called [11C]savolitinib. Researchers want to find out how much of this medicine goes into the brain when healthy people take it. This is a very early stage of research, sometimes called Phase 1, where scientists learn important things about new medicines, like how they move around the body. They aren't testing if it treats any illness in this study, just how it behaves in healthy volunteers. Understanding how much medicine reaches the brain is important for future research into conditions that might affect the brain.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

AstraZeneca AB

Enrolment target

Start

21 Mar 2024

Healthy Volunteers

What is this study about?

This research study is focused on a new medicine called [11C]savolitinib. The main goal is to carefully observe how much of this medicine actually travels into the brain after someone takes it. Think of it like watching dye spread in water – the scientists want to see how much of the medicine reaches a specific area, in this case, the brain. This is a crucial early step when developing any new medicine, especially one that might one day be used to help with brain-related conditions.

This kind of study is often called a 'human pharmacology' study or 'Phase 1'. It’s not about treating any particular illness. Instead, it’s about understanding the very basics of how a new medicine works in the human body. Researchers learn about things like how the body absorbs the medicine, how it processes it, and how it eventually leaves the body. Knowing how well [11C]savolitinib enters the brain is vital information that can help scientists decide if it’s worth continuing to study this medicine for conditions that affect the brain in future trials.

By taking part, healthy volunteers help gather this essential information. This early research lays the groundwork for all future studies that might one day lead to new treatments. It's an important piece of the puzzle in bringing new medicines safely to people who might need them.

Key takeaways

This study is about a new medicine called [11C]savolitinib.
It aims to see how much of the medicine gets into the brain in healthy people.
It is a very early stage of research, not a treatment trial.
Healthy adults (18+) of any gender can take part.
Participation involves taking the medicine and having scans/blood tests.

Who may be eligible?

To join this study, you need to be a healthy adult.

Both men and women can take part. You must be at least 18 years old – there's no upper age limit, as long as you are healthy enough to participate.

The research team will carry out some health checks to make sure you are suitable and that it's safe for you to take part.

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 healthy?
Are you willing to have blood tests?
Are you willing to have special scans?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be asked to attend a research clinic for a period of time. You would take a small amount of the study medicine, [11C]savolitinib. After taking the medicine, you would have scans (like special pictures of your brain) and blood tests. These tests help scientists see how the medicine moves into and around your brain and body.

You would have regular check-ups by the research team to make sure you are well. The total time you would be involved in the study, including all visits and follow-ups, would be explained to you in detail before you agree to take part.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. The main benefit here is contributing to medical science and helping researchers learn more about new medicines. There is no direct medical benefit to you personally. Potential risks might include discomfort from blood tests or scans, or side effects from the study medicine, though studies like this start with very low doses in healthy people. You will be closely monitored, and 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.

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Unverified
Sweden

Common questions

What is [11C]savolitinib?

It's a new medicine being studied. In this trial, researchers are just learning how it works in the body, not testing it as a treatment.

Will this study help me with a specific illness?

No, this study is not designed to treat any illness. It's focused on understanding how the medicine behaves in healthy people.

What kind of tests will I have?

You'll likely have some blood tests and special scans (like brain images) to see where the medicine goes in your body.

Do I get paid for taking part?

The study team will tell you if there is any payment or reimbursement for your time and travel if you are eligible to take part.

Can I leave the study at any time?

Yes, you can decide to stop taking part in the study at any point, and you don't need to give a reason.