An open-label, fixed sequence drug interaction study in healthy subjects to investigate the effect of multiple doses of the gastric acid-reducing agent rabeprazole on the single dose pharmacokinetics of a 40 mg deucrictiban extended-release (XR) tablet.
This study is about a new medicine called deucrictiban XR, which is being developed to treat hereditary angioedema (HAE). HAE is a rare genetic condition that causes sudden, severe swelling. The main goal of this particular study is to see how deucrictiban XR behaves in the body when someone is also taking rabeprazole, a common medicine used to reduce stomach acid, often prescribed for heartburn or indigestion. Researchers want to ensure that taking these two medicines together doesn't change how deucrictiban XR works. This type of study, called a drug interaction study, helps doctors understand the best way to prescribe medications safely and effectively for people with HAE.
At a glance
What is this study about?
This research study is looking into a new medicine called deucrictiban XR, which is designed to help people with hereditary angioedema (HAE). HAE is a rare condition that causes unexpected and sometimes life-threatening swelling in various parts of the body. Finding effective and safe treatments is very important for people living with HAE.
One important thing doctors need to know about any new medicine is how it interacts with other common medications. Many people take more than one medicine, for example, for conditions like heartburn or indigestion. This study specifically wants to see what happens when deucrictiban XR is taken at the same time as rabeprazole, which is a widely used medicine that reduces stomach acid. We want to understand if rabeprazole changes how deucrictiban XR is absorbed, used, or cleared by the body.
The information from this study will help doctors and patients make informed decisions about taking deucrictiban XR, especially if they also need to take medicines that affect stomach acid. It helps ensure that when deucrictiban XR is eventually used by patients, it will be safe and work as expected, even if they are on other common medications.
Key takeaways
- This study helps understand how a new HAE medicine interacts with a common stomach acid reducer.
- It's for healthy volunteers aged 18 and over, both men and women.
- Participation involves taking both medicines and having blood tests at a clinic.
- The goal is to ensure safe and effective use of the HAE treatment for patients.
- You won't directly benefit, but you'll contribute to important medical research.
Who may be eligible?
This study is looking for healthy volunteers, meaning people who generally don't have any major medical problems. You need to be at least 18 years old to take part, and there's no upper age limit, so adults of all ages can potentially join.
The study is open to both men and women. The most important thing is that you are in good health overall and fit specific health checks that the study team will carry out.
Because this is about medicines and how they interact, the study team will carefully check your medical history and current health to make sure it's safe for you to participate.
- Are you 18 years old or older?
- Are you generally in good health?
- Are you willing to visit a clinic for several appointments?
- Are you comfortable with having blood samples taken?
- Are you able to take study medications as prescribed?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you will be considered a healthy volunteer. This means you won't have HAE yourself, but you will help researchers understand the new medicine.
You will receive both the new medicine (deucrictiban XR) and the stomach acid-reducing medicine (rabeprazole) during the study. It's likely you will take rabeprazole for a few days before taking a single dose of deucrictiban XR. This allows the researchers to see the effect of rabeprazole on deucrictiban XR.
Taking part will involve several visits to a clinic, during which blood samples will be taken at different times to measure the levels of the medicines in your body. There will also be health checks, including physical exams and vital signs (like blood pressure and heart rate). The total duration of your participation, including screening, treatment, and follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is hereditary angioedema (HAE)?
HAE is a rare genetic condition that causes sudden and severe swelling in different parts of the body, like the face, hands, feet, or airway.
Why is this study only for healthy people?
Drug interaction studies like this often start with healthy volunteers to see how medicines behave in a body without other health complications, making the results clearer.
What is rabeprazole?
Rabeprazole is a common medicine that helps reduce the amount of acid in your stomach, often used for conditions like heartburn or indigestion.
Will I get paid for taking part?
Payment or compensation for your time and travel will be discussed by the study team, as is common in healthy volunteer studies.
How long will I be in the study?
The total duration of your participation, including all visits and follow-up, will be fully explained to you before you agree to join.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.