Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects
This research is an early study (Phase 1) looking into how a new medicine called leramistat might interact with other common medications in healthy adults. It's often called a 'drug-drug interaction' or DDI study. The main goal is to understand how your body processes leramistat when it's taken at the same time as medicines like itraconazole (an antifungal), phenytoin (for seizures), simvastatin (for cholesterol), and upadacitinib (for certain inflammatory conditions). This information is very important for doctors to know so they can safely prescribe leramistat in the future alongside other necessary treatments. Healthy volunteers aged 18 to 55 will take part, following a specific schedule of medicines, so researchers can carefully monitor what happens.
At a glance
What is this study about?
This study is called a 'Drug-Drug Interaction' (DDI) study, and it's an important early step in developing a new medicine called leramistat. Think of it like this: when you take different medicines at the same time, they can sometimes affect how each other work. One medicine might make another stronger, weaker, or stay in your body for a shorter or longer time. This study is designed to carefully watch these interactions.
Researchers will give healthy volunteers leramistat along with some commonly used medicines – itraconazole (often used for fungal infections), phenytoin (used for seizures), simvastatin (used to lower cholesterol), and upadacitinib (used for conditions like arthritis). By doing this, they can see exactly how leramistat behaves in the body when these other medicines are also present, and vice versa. This helps them understand if there are any special instructions needed for patients taking leramistat with other treatments.
Because this is an early-stage study (Phase 1), it focuses on healthy adults rather than patients who are already unwell. This allows researchers to get a clear picture of how the drugs interact without other health conditions making it complicated. The information gathered here is crucial for ensuring that leramistat can be prescribed safely and effectively in the future, once it is made available to people who need it.
Key takeaways
- This is an early study (Phase 1) of a new medicine called leramistat.
- It aims to understand how leramistat interacts with other common medications.
- Only healthy adults aged 18-55 can participate.
- Participation involves taking study medicines and having regular health checks and blood tests.
- Your involvement helps advance medical knowledge for future treatments.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you need to be a healthy adult between 18 and 55 years old. Both men and women can take part, but women must not be able to have children (for example, if they have gone through menopause or have had a medical procedure that prevents pregnancy).
There are also some reasons why you might not be able to join. For example, if you have any significant ongoing health problems, whether physical or mental, that your study doctor thinks could affect the results or put you at extra risk. This would also include any past illnesses that could make it harder to get clear results from the study.
The main idea is to make sure that participants are generally healthy, so the researchers can focus on how the study drugs interact without other health conditions getting in the way.
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 between 18 and 55 years old?
- Are you generally in good health, without any significant ongoing medical conditions?
- If you are a woman, are you unable to become pregnant (e.g., post-menopausal, had specific surgery)?
- Have you spoken with your doctor about this study and any other medications you take?
- Are you willing to follow a specific schedule of medication and clinic visits?
What does participation involve?
If you decide to take part, you will be in the study for a certain amount of time, following a specific schedule. You'll visit the study clinic regularly, where you'll receive the study medicines (leramistat and some other common drugs) according to a set plan. This might involve staying at the clinic for a few days at a time.
During your visits, the research team will take blood and urine samples to see how the medicines are processed by your body. They will also check your health frequently through physical examinations, vital signs (like blood pressure and heart rate), and asking you how you feel. All these checks are routine to monitor your safety and gather important information about the drugs. You will have follow-up appointments after taking the medicines to ensure your health remains good. The total duration of your participation will be explained to you in detail before you agree to join.
Potential risks and benefits
Locations (1)
- CelerionVerified postcodeBelfast, United Kingdom· Recruiting
Common questions
What is leramistat?
Leramistat is a new medicine that is being studied. This particular research looks at how it interacts with other drugs.
Why is this study only for healthy people?
Researchers often start with healthy volunteers in early studies to clearly understand how a new medicine works in the body and how it interacts with other drugs, without other health conditions complicating the results.
What does 'drug-drug interaction' mean?
It means how different medicines affect each other when taken together. For example, one medicine might change how your body handles another.
Will I get paid for taking part?
Compensation for your time and inconvenience is usually provided in clinical studies. The study team will tell you about any payments during the consent process.
How long will I need to be in the study?
The exact duration will vary based on the study design and the part you are involved in. The research team will explain the full time commitment before you join.
How to find out more
Study Team
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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