Effect of itraconazole on the pharmacokinetics of a single oral dose of BI 1815368 in healthy male subjects (an open-label, two-period fixed-sequence design study)
This research study, called a Phase I trial, is designed to understand how a specific medication called Sempera (a liquid solution) might interact with another experimental drug, BI 1815368. The main goal is to carefully observe how the body handles BI 1815368 when Sempera is also given. We'll be looking at two key things: how much of BI 1815368 gets into your bloodstream over time (this is called AUC), and how quickly it reaches its highest level in the blood (called Cmax). This is important because drug interactions can change how well medicines work or if they cause side effects. Only healthy men participate in this type of early study.
At a glance
What is this study about?
This study is a type of early research often called a 'Phase I' trial. In these trials, scientists look very closely at how new or existing medicines behave in the human body. Think of it like a detective story: we're trying to find out exactly where a medicine goes, how much of it gets absorbed, and how quickly it's processed after someone takes it. This particular study is interested in how two specific medicines interact with each other.
The main purpose is to see if one medicine, Sempera, changes the way the body handles another medicine, BI 1815368. This is really important because if two medicines are taken at the same time, they can sometimes affect each other. One drug might make the other stronger, weaker, or change how long it stays in the body. If we understand these interactions early on, doctors can prescribe medicines more safely and effectively in the future, making sure patients get the right amount of medicine for their needs.
Researchers will be looking at things like how much of the drug BI 1815368 gets into the bloodstream and how long it takes to reach its peak level. By observing healthy volunteers, they can get a clear picture of these processes without other health conditions making the results harder to understand. This information is a vital step in learning more about how new drugs work and how to use them safely with other treatments.
Key takeaways
- This study investigates how two medicines, Sempera and BI 1815368, interact in healthy men.
- It's a 'Phase I' study, focused on understanding how the body handles these drugs.
- Researchers will take blood samples to measure drug levels over time.
- Participation requires two visits to the study clinic.
- This research helps improve understanding of drug safety and effectiveness.
- You can withdraw from the study at any time.
Who may be eligible?
To take part in this study, you must be a healthy male adult. Being 'healthy' means that you don't have any major ongoing medical conditions that would affect how your body handles medicines. We're looking for people who are generally well and don't need regular medication for long-term health problems. This ensures that the results we get are clear and not influenced by other illnesses.
There isn't an upper age limit for this study, but you must be at least 18 years old to participate. The study is specifically designed for men. If you are female, or under 18, or have certain health conditions, this particular study would not be suitable for you.
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 a man?
- Are you 18 years old or older?
- Are you generally healthy and don't have major ongoing health conditions?
- Do you not take regular medication for long-term health problems?
What does participation involve?
If you decide to take part, you'll be asked to visit the study clinic two times. On each visit, you'll be given a dose of the study medication, BI 1815368, and at one of these visits, you'll also receive Sempera. Throughout each visit, and for a short time afterwards, we will regularly take small blood samples from you. These samples help us measure the levels of the medicines in your body over time. We might also check your vital signs like blood pressure and heart rate.
The study is designed in two parts, or 'periods,' and will happen over a fixed sequence. This means you'll undergo the same set of measurements and drug doses on two separate occasions. The total time you'll spend actively taking part in the study, including clinic visits and any follow-up, will be clearly explained before you agree to join. You'll have all the details about how many visits, how long each lasts, and when you'll take the medicines.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is a 'Phase I' study?
A Phase I study is an early stage of research where scientists look at how a new drug or drug combination behaves in the human body, focusing on safety and how the body handles the medicine.
Why do researches only want healthy men for this study?
Using healthy men helps researchers understand how the drugs work without other health conditions or hormonal changes that might make the results harder to interpret.
What does 'pharmacokinetics' mean?
Pharmacokinetics is a scientific term that describes what the body does to a drug – how it absorbs, distributes, metabolises, and gets rid of it. This study is all about understanding that process.
Will I be given a new drug?
You will be given BI 1815368, which is an investigational drug, and Sempera, which is an existing liquid medication, to see how they interact. This is not a treatment for an illness, but a study to gather information.
Will I get paid for taking part?
Information about payment or reimbursement for your time and travel will be provided in detail by the study team if you express interest in participating.
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.