Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Pharmacokinetics and the Effect of Food on the Pharmacokinetics of TW102 in Healthy Subjects.

This research study is about a new medicine called TW102. It's a very early-stage study, meaning we're testing it for the first time in people. We're looking for healthy volunteers, not people with a specific illness. The main aim is to understand how your body handles TW102. We'll find out how much of the medicine enters your bloodstream and how quickly your body gets rid of it. We also want to see if eating food at the same time as taking TW102 makes any difference to how it works. This kind of study helps us learn important information about new medicines before they can be tested in people who might need them for an illness.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Treeway TW001AD B.V.

Enrolment target

Start

12 Aug 2024

No medical condition.

What is this study about?

This study is a bit like a first look at a new medicine called TW102. It’s an important early step in developing any new treatment. We want to understand what happens when you take TW102. For example, we want to know how much of the medicine gets into your blood, how long it stays there, and how your body breaks it down and gets rid of it. This process is called 'pharmacokinetics' in medical terms, but simply put, it's about tracking the medicine's journey inside you.

Another important question we want to answer is whether eating food makes a difference to how TW102 works. Sometimes, taking a medicine with food can change how well your body absorbs it, or even cause side effects. By studying this in healthy volunteers, we can get a clear picture without any other health conditions making things complicated.

This information is really valuable because it helps scientists and doctors decide the best way to give the medicine in the future. For instance, it can help work out the right dose, or whether it should be taken with or without food. All this learning is essential before TW102 can be tested in people who are unwell and might benefit from it.

Key takeaways

This study is testing a new medicine called TW102.
It's for healthy adult volunteers, not people with an existing illness.
The main aim is to see how the medicine works in the body and if food changes this.
Participation involves taking the medicine, blood tests, and health checks.
You won't directly benefit, but you will help medical research.
You can stop taking part at any time.

Who may be eligible?

This study is looking for healthy adults. You don't need to have any particular health condition to take part. In fact, it's important that you are generally well and don't have any ongoing medical problems.

To be eligible, you must be at least 18 years old. There is no upper age limit, as long as you are considered healthy enough to participate.

Both men and women are welcome to join this study. The research team will do some checks to make sure you're suitable and healthy enough to take part safely.

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 and don't have any ongoing medical conditions?
Are you comfortable with having blood tests?
Are you able to attend study visits as required?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new medicine, TW102, likely in a hospital or clinic setting. You would have blood samples taken at different times to measure how much of the medicine is in your body. We would also check your overall health throughout the study, which might involve things like checking your blood pressure or taking urine samples. Some parts of the study might involve you staying overnight, especially when we're seeing how food affects the medicine. This is a short-term study, so your total participation would involve a few visits or perhaps a short stay, followed by some follow-up checks.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You won't directly benefit from this study, as it's not designed to treat an illness; however, you'll be helping medical science learn more about a new medicine, which could help future patients. Potential risks could include mild side effects from TW102, discomfort from blood tests, or inconvenience from study visits. All possible risks will be fully explained before you agree to take part. Remember, you can choose to stop participating in 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
Portugal

Common questions

What is TW102?

TW102 is a new medicine that is being studied for the first time in people. We are trying to understand how it works in the body.

Why is this study only for healthy people?

Because it's a very early study, using healthy volunteers helps us understand how the medicine works without other health problems making it complicated.

Will I get paid for taking part?

Compensation for your time and travel expenses is often provided for studies like this. The study team will give you full details about this.

What does 'pharmacokinetics' mean?

It's a medical term, but in simple words, it means how your body handles the medicine – how it gets into your blood, how long it stays, and how your body gets rid of it.

Can I eat normally during the study?

The study will look at how food affects the medicine, so you might be asked to eat specific meals or fast at certain times. This will all be explained clearly to you.