Relative bioavailability of two different formulations of nerandomilast and investigation of the food effect on new formulation following oral administration in healthy adult male and female subjects (an open-label, randomised, single-dose, three-way crossover trial)
This research study is about a medicine called nerandomilast. We're testing two different versions of this medicine to see how well they get into your body. We’ll also give one of the new versions with food to understand if eating affects how it works. This is important because it helps us figure out the best way for people to take the medicine in the future. The study involves healthy adult men and women and compares the different medicine versions in a careful way. This type of study is done early in a medicine's development to gather basic information about how it behaves in the body.
At a glance
What is this study about?
This study is designed to understand how a new medicine, nerandomilast, works in your body. We are specifically looking at two different ways this medicine is made, or 'formulations'. Think of it like comparing two slightly different recipes for the same cake – we want to see if they end up being absorbed by the body in the same way.
One important part of the study is to see if taking the new version of the medicine with food changes how your body takes it in. For some medicines, food can make a big difference, either helping it work better or making it less effective. By finding this out, we can give clear advice to future patients about whether to take the medicine with or without a meal.
This kind of study is called a 'Phase 1' study. It's usually the first time a new medicine is given to people, but in this case, it's focused on healthy volunteers. The goal is to gather basic information about how the medicine behaves in the body rather than to treat a specific illness. The results will help doctors and scientists decide the best way to give nerandomilast to patients in future studies.
Key takeaways
- Tests how a new medicine, nerandomilast, works in the body.
- Compares two different versions of the medicine.
- Checks if food affects how the medicine is absorbed.
- Involves healthy adult men and women (18+).
- Participation includes taking medicine and blood tests.
- Helps understand the best way to take nerandomilast in the future.
Who may be eligible?
This study is looking for healthy adults to take part. This means we're not looking for people with specific illnesses, but rather those who are generally well.
Both men and women are welcome to participate. You need to be at least 18 years old to join the study.
- Are you generally healthy?
- Are you 18 years old or older?
- Are you comfortable with taking a new medicine?
- Are you willing to have regular blood tests?
- Are you available for study visits over a period of time?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you will be openly assigned to receive doses of nerandomilast as part of a three-part study. You'll switch between the different versions of the medicine, and sometimes you'll take it with food. This means you will receive both types of the medicine we are testing over the course of the study.
During your time in the study, you'll have several visits to the clinic for check-ups. We will take blood samples to measure how much of the medicine is in your body and how it's being processed over time. You will need to take the study medicine as instructed. The total duration of your participation will involve these visits, taking the medicine, and follow-up checks, which will be clearly explained to you before you start. You'll receive a full schedule if you're interested.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is nerandomilast?
Nerandomilast is a new medicine being developed. This study aims to understand how it behaves in the human body.
Why are you looking for healthy volunteers?
We recruit healthy volunteers for early studies like this to understand how the medicine works in a typical body before testing it in people with specific health conditions.
What does 'formulation' mean?
A 'formulation' is the way a medicine is made – for example, as a tablet, capsule, or liquid. We're testing two slightly different ways of making nerandomilast.
Will I know which medicine version I am taking?
Yes, this is an 'open-label' study, which means you and the study team will know which version of the medicine you are receiving at any given time.
How long will the study last for each participant?
The exact duration for each person will be explained to you in detail if you consider joining, as it involves several visits and follow-ups over a period.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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