A Phase I, open-label, randomized, two period, cross-over study in healthy subjects to assess the bioavailability of different formulations of deucrictibant administered as single dose under fasting condition.
This research study is about a new medicine called deucrictibant, which is being developed to help people with hereditary angioedema (HAE). HAE is a rare condition that causes sudden swelling in different parts of the body. In this study, we want to understand how different ways of giving this new medicine (called 'formulations') are absorbed into your body when you take it on an empty stomach. We're looking for healthy volunteers, aged 18 and older, to take part. You’ll receive a single dose of the medicine, and doctors will take blood samples to see how much medicine gets into your system. This early stage study helps us find the most effective and safe way to use this new treatment in the future.
At a glance
What is this study about?
This study is an early-stage research project designed to help us learn more about a new medicine called deucrictibant. This medicine is being developed to treat hereditary angioedema, often shortened to HAE. HAE is a rare genetic condition that causes unexpected and often painful swelling in various parts of the body, like the face, hands, feet, or even internal organs, which can be very serious.
The main goal of this particular study is to compare different versions of the deucrictibant medicine. Think of it like comparing different ways a drug might be packaged or made (e.g., a tablet versus a liquid form) to see which one works best. We want to find out how well each version is absorbed into the bloodstream after someone takes just one dose.
By understanding how the body takes in the medicine, we can choose the best version for future studies and, eventually, for people who need this treatment. This is a very important step to make sure that when this medicine is finally used for HAE patients, it will be as effective and safe as possible. These early studies with healthy volunteers are crucial before testing it in patients who have the condition.
Key takeaways
- This study is testing different versions of a new medicine for hereditary angioedema (HAE).
- It aims to find out how well the medicine is absorbed into the body.
- Healthy adults aged 18 and over, both men and women, are eligible to join.
- Participation involves clinic visits, taking a single dose of medicine, and having blood tests.
- You will be helping to develop a new treatment for a serious condition.
- You can always change your mind and leave the study at any point.
Who may be eligible?
To join this study, you need to be a healthy adult aged 18 or older. Both men and women are welcome to take part.
Because this is an early study to see how a new medicine works in the body, we are looking for people who don't have any major health problems. This helps us to see the effects of the medicine clearly without other conditions complicating the results.
The research team will carry out some checks to make sure you are healthy enough and that taking part is safe for you. They will review your medical history and might do some basic health tests.
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?
- Do you consider yourself generally healthy?
- Are you able to visit a clinic for several hours or potentially overnight?
- Are you comfortable with having blood samples taken?
- Are you willing to follow specific study instructions, like fasting before taking medicine?
What does participation involve?
If you decide to join this study, here’s what you can expect. You will be asked to visit the study clinic on several occasions. During these visits, you will receive a single dose of the study medicine, called deucrictibant. This will be given on an empty stomach. Healthcare professionals will then take blood samples from you at different times over a set period. These blood samples help us measure how much of the medicine is in your body and how it's being processed.
Because this is a 'cross-over' study, you might receive different versions of the medicine at different times, with a break in between. This allows researchers to compare the different versions within the same person. Each visit or 'period' will involve taking the medicine and having blood tests. The total time you'd be involved in the study, including all visits and follow-ups, will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is hereditary angioedema (HAE)?
HAE is a rare condition that causes sudden and painful swelling in different parts of the body, like the hands, feet, face, or tummy. This swelling can be severe and sometimes dangerous.
Why is this study only looking for healthy people?
In these early studies, it's important to test the new medicine in healthy volunteers first. This helps us understand how the medicine works in the body without other health conditions affecting the results, making it safer for future patient studies.
Will I have to stay overnight at a clinic?
The study team will explain the exact schedule, but studies like this often involve extended stays at the clinic for several hours or even overnight after taking the medicine, so blood tests can be done at specific times.
Will I get paid for taking part?
Often, studies like this offer payment for your time and to cover any travel expenses. The study team will be able to confirm this information with you.
What does 'single dose' mean?
It means you will only receive the study medicine one time during each study period, rather than taking it regularly over many days or weeks.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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