A trial to learn how well different doses of andexanet alfa work and how they affect blood clotting throughout the body in healthy adults who have taken an FXa inhibitor
Many people take blood-thinning tablets known as Factor Xa (FXa) inhibitors to stop dangerous blood clots from forming. However, if a person has an accident or needs urgent surgery, doctors need a way to quickly switch off the blood thinner to prevent dangerous bleeding. Andexanet alfa is a medicine designed to act as an antidote, turning off the blood thinner so the blood can clot normally again. This early-stage clinical trial is testing different doses of andexanet alfa in healthy adult volunteers who are given a short course of a blood thinner. The main goal is to find out how well each dose works, how fast it acts, and how safe it is throughout the body. The results will help doctors choose the best dose for patients facing bleeding emergencies in the future.
At a glance
What is this study about?
Blood thinners are life-saving medicines used by millions of people across the UK to prevent strokes and deep vein blood clots. A very common type of blood thinner is called a Factor Xa (FXa) inhibitor. While these medicines are very effective, they can sometimes cause problems. If someone taking an FXa inhibitor has a major injury or needs emergency surgery, their blood cannot clot normally, which can lead to severe or life-threatening bleeding.
To solve this, scientists developed a medicine called andexanet alfa. It acts like a biological sponge, soaking up the blood thinner in the bloodstream so that the body's natural clotting system can get back to work. In emergency medicine, having an effective 'reversal agent' or antidote can save lives.
This trial is being carried out with healthy volunteers to study andexanet alfa in a controlled, safe environment. Participants first receive a blood thinner, and then they receive different doses of andexanet alfa. By measuring blood samples very closely, researchers can see exactly how the body responds to each dose.
Understanding the precise effects of different doses helps doctors know how much medicine to give in real-world emergencies. This ensures future patients get a dose that stops bleeding effectively without causing unwanted side effects.
Key takeaways
- The trial tests different doses of andexanet alfa, an antidote to common blood thinners.
- It aims to find out how quickly and safely the medicine restores normal blood clotting.
- Participants must be healthy adults aged 18 and over.
- Taking part involves receiving a temporary blood thinner and the study medicine, followed by regular blood tests.
- Participation is entirely voluntary, with close medical supervision throughout.
Who may be eligible?
This trial is open to healthy adults who are aged 18 or older. Because this is an early-stage study looking at how a medicine behaves in the human body, researchers need people who are in generally good health and free from major long-term illnesses.
You will not be able to take part if you have a history of serious health conditions, such as heart disease, kidney problems, liver disease, or previous blood clotting disorders. You also cannot join if you are already taking regular medications that affect blood clotting.
Women who are pregnant, planning to become pregnant, or currently breastfeeding will not be eligible to join, as the effects of the study drug on unborn babies or infants are not fully known. The study team will run health checks and blood tests to make sure it is 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.
- I am aged 18 or older.
- I consider myself to be in good general health.
- I do not have a personal history of blood clots or bleeding problems.
- I am not currently taking regular blood-thinning medications.
- I am not pregnant, planning a pregnancy, or breastfeeding.
- I am comfortable having blood samples taken and attending clinic visits.
What does participation involve?
Taking part in this study involves several steps over a set period. First, you will attend a screening visit where doctors check your medical history, perform a physical examination, and take blood and urine samples. If you are eligible, you will be given an FXa inhibitor blood thinner for a short time, followed by an infusion of andexanet alfa into a vein through a small drip.
You will be monitored closely in a clinical research unit, which may involve an overnight stay or several hours of close observation. The team will regularly check your blood pressure, heart rate, and take repeated blood samples to measure how quickly your blood clots. After the treatment, you will have follow-up visits to check that your body has returned completely to normal. The study team will explain the exact schedule and time commitment before you decide to take part.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is an FXa inhibitor?
It is a type of blood-thinning medicine that blocks a protein in your blood called Factor Xa. This slows down clotting to help prevent dangerous blockages in blood vessels.
Why test this medicine on healthy people?
Healthy volunteers help scientists see how a medicine works in a clean, controlled setting without interference from other illnesses or daily medications.
Will taking a blood thinner put me in danger?
You will be given the medicine in small, carefully controlled amounts and will be watched closely by doctors in a medical clinic to ensure your safety.
Can I leave the study if I change my mind?
Yes. You have the right to withdraw from the study at any point, and your future NHS care will not be affected in any way.
Will I be paid for taking part?
Phase 1 trials with healthy volunteers usually provide payment or cover travel expenses to compensate you for your time. The study team can give you specific details.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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