A study comparing the new drug PG413 produced by Celon Pharma SA with the drug Eliquis available on the market in healthy volunteers.
This research is looking at a new medicine called PG413, made by Celon Pharma SA. We want to compare it to a medicine that's already available, called Eliquis. Both medicines are designed to help people who are at risk of strokes, particularly those with a heart condition called atrial fibrillation. They also help treat and prevent blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism). This is a very early stage study, involving healthy volunteers, to understand how PG413 behaves in the body. It's about checking if the new medicine acts in a similar way to the existing one. This kind of research is an important step before a new medicine can be tested in people who are unwell.
At a glance
What is this study about?
This study is investigating a new medicine called PG413. The main goal is to see how this new medicine compares to an existing, common medicine called Eliquis. Both PG413 and Eliquis are designed to help people with certain medical conditions, mainly to prevent strokes and treat blood clots.
The conditions these medicines address include preventing strokes in people who have a heart rhythm problem called non-valvular atrial fibrillation (often shortened to NVAF). This is particularly important for individuals who have other risk factors, such as having had a stroke or a mini-stroke (TIA) before, being over 75, having high blood pressure, diabetes, or certain levels of heart failure. These medicines also help treat and prevent blood clots that can form in the legs (known as deep vein thrombosis or DVT) or travel to the lungs (called pulmonary embolism or PE).
This particular study is a very early stage of research, called a 'Phase I' study. It involves healthy volunteers rather than people with the conditions mentioned. The purpose of this phase is to carefully examine how the new medicine, PG413, is absorbed, used, and removed by the body, and to check if it acts in a similar way to Eliquis. This information is crucial for understanding the new medicine better before it can be tested in patients who might benefit from it. It's a key step in developing new treatments.
Key takeaways
- This study compares a new medicine (PG413) to an existing one (Eliquis).
- It's designed for healthy adult volunteers.
- The medicines are for preventing strokes and treating blood clots.
- Your participation helps to develop new treatments for the future.
- All health checks and tests will be explained in detail.
- You can withdraw from the study at any time.
Who may be eligible?
To take part in this study, you need to be a healthy adult. This means you generally don't have any major ongoing health problems, especially those related to your heart or blood clotting.
We are looking for both men and women to join the study. You must be at least 18 years old to be considered.
More detailed checks will be done by the study team to make sure it's safe and appropriate for you to participate. These checks will ensure you meet all the health requirements for healthy volunteers.
- Are you 18 years old or older?
- Are you generally in good health?
- Are you available for several clinic visits?
- Are you comfortable with blood tests?
- Are you able to follow study instructions carefully?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
As a healthy volunteer in this study, you would receive doses of either the new medicine, PG413, or the existing medicine, Eliquis. The study team will explain exactly how this will work. You would need to attend several appointments at the study clinic or hospital. These visits would involve taking the study medicine, having blood samples taken, and undergoing other health checks to see how the medicine is affecting your body. We will monitor your health closely throughout the study for a specific period. You will be told the total time commitment required upfront, including how many visits and how long each visit might last, as well as any follow-up appointments.
Potential risks and benefits
Locations (1)
- —Poland
Common questions
What is the purpose of this study?
The study aims to compare a new medicine, PG413, with an existing medicine, Eliquis, to see how they work in healthy people.
Who can take part in this study?
Healthy adults aged 18 and older, both men and women, can potentially take part.
Will I receive the new medicine or the existing one?
Participants will be given either the new medicine (PG413) or the existing medicine (Eliquis) to help the researchers compare them. You won't know which one you're getting at the time.
What kind of tests will I have?
You will have blood tests and other health checks at study appointments to see how the medicine is affecting you.
Will I be paid for taking part?
The study information will provide details about travel expenses or any compensation for your time. This will be explained clearly before you agree to take part.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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