A Phase I, Open-Label, Randomized, Two-Period, Cross-Over Study in Healthy Subjects to Assess the Influence of a High-Calorie, High-Fat Meal on the Bioavailability of a 40 mg Extended-Release (XR) Deucrictibant Oral Formulation Administered as a Single Dose.
This study is a Phase I trial, which means it's an early-stage study in healthy volunteers. It's designed to understand how a new form of a medicine called deucrictibant is absorbed by the body when taken by mouth. Specifically, researchers want to see if eating a high-calorie, high-fat meal changes how well the medicine is absorbed and how much of it reaches the bloodstream, compared to taking it without such a meal. This particular type of deucrictibant is an 'extended-release' tablet, meaning the medicine is released slowly over time. Understanding this helps ensure the medicine will work effectively for people with conditions like hereditary angioedema (HAE), for which this drug is being developed.
At a glance
What is this study about?
This study is an important first step in understanding a new medicine called deucrictibant. Imagine it like a test drive for a new car – we're checking how it performs in a controlled setting before it’s used more widely. The medicine is being developed to treat a condition called hereditary angioedema or HAE. People with HAE can have sudden and severe swelling attacks that can be very painful and even dangerous.
In this study, healthy volunteers are taking a special 'extended-release' version of deucrictibant. Extended-release means the medicine is designed to release its active ingredient slowly and steadily over many hours, which can be more convenient for patients. The main thing we want to find out is whether eating a big, fatty meal affects how much of this medicine gets into the body and at what speed. For some medicines, food can make a big difference, either helping or hindering how well it's absorbed.
Understanding how food affects the medicine is really important. If we know this, doctors can give clearer advice on how to take the medicine – whether it's best with food, without food, or if food doesn't matter. This helps to make sure that when patients with HAE eventually take deucrictibant, they get the right amount of medicine into their system so it can work as effectively and safely as possible to prevent or treat their swelling attacks.
Key takeaways
- This is an early-stage study in healthy volunteers.
- It's testing a new extended-release medicine for hereditary angioedema (HAE).
- The main goal is to see if a fatty meal affects how the medicine is absorbed.
- Participants will take the medicine twice, once with a fatty meal and once differently.
- Results will help doctors understand how to recommend taking the medicine in the future.
- It contributes to developing new treatments for HAE patients.
Who may be eligible?
To join this study, you need to be a healthy adult aged 18 years or older. This means you shouldn't have any major ongoing health problems or be taking regular medication that could interfere with the study medicine.
The study involves people with all sexes, so both men and women can take part. Because this is an early-stage study, it's designed for healthy volunteers, not for people who currently have hereditary angioedema.
More detailed checks will happen if you express an interest, to make sure it's safe for you to participate and that your results will help the researchers understand the medicine correctly.
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 18 years old or older.
- I am in good general health.
- I am not currently taking any regular medications that might interfere with the study (this will be checked by doctors).
- I am willing to follow study instructions, including dietary requirements for some visits.
- I am available to visit the study clinic for the required period.
- I am comfortable with having regular blood tests.
What does participation involve?
If you decide to take part in this study, you'll be giving a new medicine a 'test run'. You will stay at the study clinic for a set period. During this time, you'll be given the deucrictibant extended-release tablet as a single dose on two separate occasions. On one occasion, you'll take it after eating a special high-calorie, high-fat meal. On the other, you'll take it in a different way (e.g., after fasting, meaning you haven't eaten for a while). The order of these two occasions will be decided randomly.
Throughout the study, nurses and doctors will regularly take blood samples to measure how much of the medicine is in your body over time. They will also check your health frequently, including your blood pressure, heart rate, and temperature, and ask you about any feelings or symptoms you experience. The total time you'll spend taking part in the study, including all visits and follow-ups, will be explained fully before you decide to join.
Potential risks and benefits
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Common questions
What is hereditary angioedema (HAE)?
Hereditary angioedema (HAE) is a rare genetic condition that causes sudden and painful swelling, often in the skin, gut, or airways. These attacks can be very uncomfortable and sometimes serious.
Why is this study only for healthy people?
Because this is a very early-stage trial (Phase I), it's important to first understand how the medicine behaves in healthy volunteers, without other health conditions complicating the results. This helps ensure it's safe enough for further testing in people with HAE.
What does 'extended-release' mean?
'Extended-release' means the medicine is designed to slowly release its active ingredients into your body over several hours, rather than all at once. This can make it more convenient to take and maintain a steady level of medicine.
How does food impact medication?
For some medicines, eating specific foods, especially high-fat meals, can change how quickly and how much of the medicine gets absorbed into the bloodstream. This study aims to find out if that's the case for this new medicine.
Will I get paid for taking part?
Study participation often includes payment for your time and inconvenience, and coverage of any travel expenses. The exact details will be explained to you by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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