Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A phase 1 study to assess the mass balance, pharmacokinetics, metabolism, and excretion of GSBR-1290, containing a microtracer dose of [14C] GSBR-1290, in healthy participants

This study is a very early step in testing a new medicine called GSBR-1290. It's designed for healthy people to help scientists understand exactly how this new medicine behaves inside the body. They want to see how much of it gets into the bloodstream, how the body processes it, and finally, how it leaves the body. To do this, participants will receive a tiny, safe dose of GSBR-1290 that has a special label on it, almost like a tiny tracker. This helps researchers follow its journey through the body with great accuracy. This type of study is crucial for ensuring potential future medicines are safe and effective.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Structure Therapeutics Inc.

Enrolment target

Start

14 Jun 2024

Not applicable - Healthy volonteers

What is this study about?

Imagine you take a new medicine. Have you ever wondered what happens to it once it enters your body? This study, called a Phase 1 study, is designed to answer exactly those kinds of questions for a new medicine called GSBR-1290. It's a very early and important step in developing any new medication. Scientists need to understand how the medicine is taken in by your body (that's called 'absorption'), how it might be changed by your body (that's 'metabolism'), and finally, how your body gets rid of it (that's 'excretion'). All of this helps them figure out the right dose and how often the medicine might need to be taken in the future.

To get a really detailed picture, participants in this study will receive a very small, safe amount of GSBR-1290 that has a special, harmless tag on it. Think of it like putting a tiny, invisible tracker on the medicine. This makes it much easier for researchers to follow its journey through the body using special tests. They can see how quickly it gets into your blood, where it might go, and how your body breaks it down and gets rid of it.

Because this is such an early study, it's carried out in healthy volunteers – people who are generally well and not taking the medicine for a particular illness. This helps researchers focus purely on how the medicine itself behaves without other health conditions affecting the results. The information gathered from this study is vital for deciding if and how this medicine should be tested further in people who might eventually benefit from it.

Key takeaways

This study helps scientists understand how a new medicine works in the body.
It's an early-stage study for healthy adult volunteers.
A tiny, safe tracker helps follow the medicine's journey inside the body.
Participation will involve visits and providing blood/urine samples.
You won't receive treatment for an illness, but your participation is key to future medicine development.
You can stop participating at any time.

Who may be eligible?

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 take part.

Both men and women are welcome to volunteer for this study. The researchers want to get a broad understanding of how the medicine works in different people.

Since this is a study about how a new medicine moves through the body, they're looking for healthy volunteers. This means you should generally be in good health. The medical team will check this carefully during the screening process to make sure 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 in good health?
Are you comfortable with potential clinic stays and regular sample collections?
Are you a man or a woman?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check your general health and make sure you're suitable for the study. If you qualify, you'll be given a single, very small dose of the study medicine, GSBR-1290, which contains a tiny, safe tracker. You'll likely need to stay at a research clinic for a period, perhaps a few days, so the team can collect blood and urine samples regularly. This helps them track the medicine's journey through your body. There might be some follow-up visits after you leave the clinic to make sure everything is okay and to collect any final samples. The total duration of your involvement, including all visits and follow-ups, will be explained in detail before you agree to participate.

Potential risks and benefits

Taking part in any medical study carries some potential risks, though these are usually kept to a minimum in Phase 1 trials like this one. You might experience some mild side effects from the medicine or discomfort from blood tests. The special 'tracker' within the medicine is used in extremely small, safe amounts, but any potential exposure will be fully explained. While there's no direct health benefit to you from taking this medicine, your participation is invaluable to medical science, helping researchers understand new medicines and potentially develop future treatments for others. Remember, you can always 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
Netherlands

Common questions

What is a 'Phase 1' study?

A Phase 1 study is one of the very first steps in testing a new medicine. It's usually done in healthy volunteers to understand how it works in the body and if it's safe.

What does 'mass balance' mean?

It means the researchers are trying to account for all of the medicine that goes into your body – seeing how much is absorbed, changed, and how much leaves your body.

What is a 'microtracer dose of [14C] GSBR-1290'?

It's a tiny, safe amount of the medicine with a special, harmless tag on it (called Carbon-14). This helps researchers track its journey through your body very accurately.

Will this medicine treat a disease?

No, not at this stage. This study is purely to understand how the medicine behaves in healthy people, not to treat any specific illness.

How long will I be involved in the study?

The exact time will depend on the study design, but it will involve a few visits or a short stay at a clinic, plus follow-up checks. The research team will tell you the precise duration.