A Study to find out the safety, tolerability and interaction of drug with body (including the effect of Itraconazole on RO7268489) and also what the body does to RO7268489 after oral intake by healthy participants
This research study is about a new medicine, currently known as RO7268489. The main goal is to understand how safe this medicine is when healthy people take it. We also want to find out how well people tolerate it, meaning if they have any side effects and how strong those effects might be. Another important part of the study is to see what the body does to the medicine after it's taken by mouth – how it's absorbed, distributed, and eventually leaves the body. Finally, we're looking into whether taking another medicine called Itraconazole at the same time changes how RO7268489 behaves in the body. This is a very early stage study, focusing on understanding the medicine itself.
At a glance
What is this study about?
This study is about a new medicine called RO7268489. When a new medicine is developed, scientists need to understand a lot about it before it can be given to patients who might need it. This particular study is one of the very first stages of testing a new medicine in people. It's called a 'Phase I' study, which means we're focusing on understanding the basics of the medicine.
The main things we want to learn are: Is it safe for people to take? Do people taking it feel okay, or do they experience uncomfortable side effects? We also want to track what happens to the medicine once it's swallowed. This includes how much of it gets into the blood, how long it stays there, and how the body eventually gets rid of it. This information helps us understand how a medicine works and what the right amount (dose) might be.
Another important question this study aims to answer is whether taking another common medicine, Itraconazole, at the same time affects how RO7268489 works in the body. Sometimes, one medicine can change the way another medicine is handled by the body, so it's vital to check for these interactions early on.
Key takeaways
- This is an early-stage study (Phase I) of a new medicine.
- It aims to find out if the new medicine is safe and how the body handles it.
- Healthy adult volunteers, aged 18 and over, are needed.
- The study will also check if another medicine (Itraconazole) affects the new medicine.
- There's no direct health benefit for participants, but you'll contribute to medical research.
Who may be eligible?
This study is currently looking for healthy adult volunteers to take part. To be eligible, you must be at least 18 years old. There is no upper age limit, meaning adults of any age above 18 can be considered.
Both men and women are welcome to participate in this research study, as sex is not a factor for eligibility. The study particularly seeks healthy individuals because the main goal is to understand how the new medicine behaves in a typical body, without other health conditions that might complicate the results.
Specific details about other health conditions, medications you might be taking, or other lifestyle factors that could impact your suitability would be discussed with the study team. Being healthy helps ensure we get clear information about the new medicine itself.
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?
- Are you willing to discuss all medicines you currently take?
- Are you available for multiple visits to a study clinic?
- Are you comfortable with blood tests and health checks during the study?
What does participation involve?
If you decide to take part, you would need to visit the study clinic or site at specific times. During these visits, you might have blood samples taken, and your general health, like your heart rate and blood pressure, will be checked regularly. You will be given the study medicine, RO7268489, to take, and possibly Itraconazole as well. The study team will explain exactly how and when to take these.
There won't be any specific follow-up appointments after your final visit to the clinic. The total duration of your participation in the study, including all visits and taking the medicine, will be explained in full detail by the study team. They will ensure you understand the full schedule and what is expected of you at each step.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is RO7268489?
RO7268489 is a new medicine being tested. It doesn't have a common name yet, as it's still in the early stages of research.
Why is this study being done on healthy people?
Studies like this are done on healthy people first to understand how the medicine works in the body without other health conditions making it complicated. This helps us learn about its safety and how it is processed by the body.
What does 'Phase I' mean?
Phase I means it's a very early stage of testing a new medicine in humans. The main goals are to check how safe it is and how the body handles it, rather than seeing if it treats a specific illness.
Will I get paid to participate?
The study information provided doesn't mention payment. This would be something important to ask the study team directly if you are considering taking part.
What is Itraconazole and why is it part of the study?
Itraconazole is a medicine used for fungal infections. In this study, it's being used to see if it changes how the new medicine, RO7268489, acts in the body, as some medicines can affect how others are processed.
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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