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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Comparative Pharmacokinetic of S221237 Tablets in Healthy Participants Under Fed Conditions

This research is investigating a new medication known as S221237. The main goal is to understand how your body takes in, processes, and gets rid of this medicine when you've recently eaten. This is an early-stage study, sometimes called a Phase 1 study, which focuses on understanding the drug's behaviour in healthy people rather than testing its effectiveness against a specific illness. Scientists call this 'pharmacokinetics.' By studying how the medicine moves through the body, researchers can learn important information that helps them plan future studies, making sure any later tests are as safe and useful as possible. This particular study is only looking for healthy men to participate.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Institut De Recherches Internationales Servier IRIS, Institut De Recherches Internationales Servier IRIS
Enrolment target
16
Start
04 Jun 2024

What is this study about?

This study is looking into a new medication called S221237. When scientists develop a new medicine, they need to understand exactly what happens to it inside the human body. This includes learning how quickly the body absorbs the medicine after it's taken, how it travels through the bloodstream, how it's broken down, and finally, how the body gets rid of it. This whole process is called 'pharmacokinetics.'

In this particular study, researchers want to see if eating food affects how S221237 behaves in the body. Sometimes, taking a medicine with food can change how well it's absorbed or how long it stays in your system. Understanding this is really important because it helps doctors and pharmacists give clear instructions on how to take the medicine for the best results.

This is an early-stage study, often called a 'Phase I' study. These types of studies are crucial for gathering basic information about a new drug in healthy volunteers. They help ensure that a drug is safe enough to be tested in larger groups of people later on, who might have specific health conditions. It's about building a strong foundation of knowledge for potential future treatments.

Key takeaways

  • This study is for healthy men aged 18 and over.
  • It's an early-stage study to understand how a new medicine, S221237, works in the body.
  • Researchers want to see if taking the medicine with food changes how your body handles it.
  • Participation involves taking the medicine and having regular blood tests.
  • You will be closely monitored by medical staff during the study.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be a healthy man, at least 18 years old. There's no upper age limit, but you'll need to be in good general health.

Because this study aims to understand how the medicine works in healthy individuals, you cannot have any ongoing medical conditions that might affect how your body handles the medication. This includes things like heart, kidney, or liver problems. You'll also need to be able to follow all the study instructions carefully.

This study is specifically looking for male participants. If you are female, or if you have any existing health issues, this particular study would not be suitable for you.

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.

  1. Are you a man?
  2. Are you 18 years old or older?
  3. Are you generally in good health with no ongoing medical conditions?
  4. Are you able to attend several clinic visits, possibly including overnight stays?
  5. Are you comfortable with having regular blood samples taken?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the medication S221237 by mouth. Because the study wants to see the effect of food, you will likely be asked to take the medicine after eating a meal. Throughout the study, the research team will regularly take blood samples from you. These samples help them measure how much of the medication is in your body at different times. They will also keep an eye on your general health and well-being. The study will involve several visits to the clinic, and you might need to stay overnight for some parts of it. The total time you'll be involved in the study will be explained to you by the research team.

Potential risks and benefits

Participating in research studies like this can offer some benefits, such as contributing to scientific knowledge that might help others in the future and receiving careful medical monitoring during the study period. However, there are also potential risks, including possible side effects from the study medication, discomfort from blood tests, and the time commitment involved. You will be fully informed of all known risks before you agree to take part. It's very important to remember that joining a study is always your choice, and you are free to withdraw 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.
  • Unverified
    Portugal

Common questions

What is S221237?

S221237 is a new experimental medicine that is being studied. It's not yet available for general use.

Why is it important to take the medicine with food?

Taking medicine with food can sometimes change how your body takes it in. This study aims to understand that specific effect for S221237.

Will I get paid for taking part?

Some studies offer payment for your time and inconvenience, but this will be clearly explained by the research team if applicable.

What are 'pharmacokinetics'?

It's a scientific term that describes what your body does to a drug – how it absorbs it, moves it around, breaks it down, and removes it.

Is this study meant to treat a disease?

No, this is an early-stage study in healthy people focused on understanding the drug itself, not treating an illness.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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