An open-label cocktail drug-drug interaction (DDI) clinical study to assess the effect of multiple oral dosing with leniolisib on the pharmacokinetics (PK) of caffeine, midazolam, rosuvastatin, furosemide, and metformin in healthy subjects
This research is looking at a new medicine called leniolisib, designed to help people with a condition known as Activated PI3K Delta Syndrome (APDS). The main goal is to understand how leniolisib interacts with other common medicines like caffeine, a sleeping aid, a cholesterol medicine, a water tablet, and a diabetes medicine. Researchers want to see if taking leniolisib changes how these other medicines work in your body. This is an early-stage study involving healthy volunteers, meaning we're not yet testing it on patients with APDS. By checking these interactions, scientists can make sure that leniolisib will be safe and effective when patients with APDS need to take it alongside other medications in the future.
At a glance
What is this study about?
This study is a very early step in developing a new medicine called leniolisib. This medicine is designed for people who have a rare condition called Activated Phosphoinositide 3-Kinase Delta Syndrome (often shortened to APDS). APDS is a genetic condition that affects the immune system, making people more prone to infections and other health issues.
The main purpose of this study is not to treat APDS directly, but to understand how leniolisib behaves in the body, especially when taken with other common medicines. Think of it like this: if you take a new vitamin and also have your usual cup of tea, does the vitamin change how your body handles the caffeine in the tea? This study uses a similar idea, but with a new medicine and several common prescription drugs.
Researchers want to see if leniolisib affects how medicines like caffeine, a sleeping tablet (midazolam), a cholesterol-lowering drug (rosuvastatin), a 'water tablet' for swelling (furosemide), and a diabetes medicine (metformin) work in your body. This information is really important because people often need to take more than one medicine. By understanding these interactions early on, doctors can ensure that when leniolisib is eventually given to patients with APDS, it won't cause unexpected problems or make other important medicines less effective.
Key takeaways
- This is an early-stage study for a new medicine called leniolisib.
- It's designed for people with Activated PI3K Delta Syndrome.
- The study looks at how leniolisib interacts with common medicines in healthy volunteers.
- Participation involves taking leniolisib and other medicines, with regular blood tests.
- The goal is to ensure leniolisib is safe to use with other treatments for future patients.
Who may be eligible?
This study is looking for healthy adults to take part. To be considered, you must be 18 years old or older. There is no upper age limit mentioned.
Both men and women are welcome to participate in this research. The study needs a variety of people to help understand how the new medicine works in general.
Because this is an early-stage study, it's open to healthy individuals, not people currently living with Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS). This helps researchers understand the basic effects of the medicine in a straightforward way before testing it in patients who might have other health complexities.
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?
- Are you generally healthy, without any major ongoing health conditions?
- Are you comfortable potentially staying at a clinic for short periods?
- Are you willing to have regular blood tests and medical check-ups?
What does participation involve?
If you join this study, you would be taking the new medicine, leniolisib, every day for a set period. You would also be given small, carefully controlled doses of other common medicines (like caffeine, a sleeping aid, a cholesterol medicine, a water tablet, and a diabetes medicine) to see how your body handles them while you are taking leniolisib. This is often done in a hospital or clinic setting with close monitoring.
You can expect regular visits to the clinic, which will likely involve blood tests to measure the levels of the medicines in your system. There might also be other assessments, like checking your heart rate or blood pressure, to ensure you are well. These studies often involve a stay in a clinical research unit for a few days at a time.
The total duration of your involvement could vary, but these early-stage studies typically last a few weeks, including follow-up appointments after you stop taking the medicine. All procedures will be clearly explained to you before you agree to take part.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is Activated PI3K Delta Syndrome (APDS)?
It's a rare genetic condition that weakens the immune system, making people more likely to get infections and other health problems.
Why are healthy people needed for this study?
Using healthy volunteers first helps researchers understand how the new medicine works on its own, without other health conditions making things more complicated.
Will I receive the actual medicines for APDS?
No, this study is about a potential new medicine (leniolisib) for APDS, but it's not a treatment study for people with the condition. It's focused on drug interactions.
What do 'drug-drug interactions' mean?
It means how one medicine affects the way another medicine works in your body. It's important to know if medicines change each other's effects.
Will I get paid for taking part?
Some studies offer payment for your time and expenses. This will be explained in detail if you inquire about the study.
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.