A Phase 1, 2-part, open-label, single-sequence study to investigate the effect of single and multiple doses of obefazimod on the pharmacokinetics of rosuvastatin in healthy male participants.
This study is an early-stage look into how a new medicine, obefazimod (which is being developed for a gut condition called ulcerative colitis), behaves in the body when taken alongside a common cholesterol medicine called rosuvastatin. Researchers want to understand if obefazimod changes how much rosuvastatin stays in the body or how quickly it's removed. This is important information for future patients who might need both medicines. The study involves healthy men and will give them single and multiple doses of obefazimod to see its effects on rosuvastatin. It's a key step in understanding how new medicines might interact with existing ones, aiming to make sure they are safe and work effectively together.
At a glance
What is this study about?
When new medicines are being developed, it's really important to understand how they interact with other medications people might already be taking. This particular study is looking at a new medicine called obefazimod, which is being investigated as a treatment for a gut condition called ulcerative colitis. Ulcerative colitis causes inflammation and sores in the large intestine.
The main goal of this study is to see how obefazimod affects another medicine called rosuvastatin. Rosuvastatin is a commonly prescribed medicine used to lower cholesterol levels and prevent heart disease. Researchers want to find out if taking obefazimod at the same time changes how rosuvastatin is handled by the body – for example, if it changes how much rosuvastatin gets into the bloodstream or how quickly it's removed.
Understanding these interactions is a crucial step in developing new medicines. It helps doctors know if they need to adjust the dose of one medicine or the other when patients are taking both. This study focuses on healthy male volunteers because it allows researchers to get a clear picture of how these medicines interact without other health conditions making the results harder to interpret. It's all part of making sure new medicines are as safe and effective as possible for everyone.
Key takeaways
- This study looks at how a new gut medicine (obefazimod) affects a heart medicine (rosuvastatin).
- It aims to understand how these medicines interact in the body.
- Only healthy men aged 18 and over are eligible.
- Participation involves taking both medicines and having blood tests.
- It's an early-stage study, important for future patient safety and treatment planning.
Who may be eligible?
This study is specifically looking for healthy male volunteers. To take part, you need to be at least 18 years old – there's no upper age limit mentioned, but you'll need to be in good general health.
The main reason they are looking for healthy men is to clearly see how the medicines interact without other health issues potentially complicating the results. This helps them understand the basic drug interaction before testing it in patients with ulcerative colitis.
If you are a man over 18 and generally feel well, you might be eligible. However, a detailed health check will be done by the study team to confirm you meet all their health criteria.
- Are you a man?
- Are you 18 years old or older?
- Are you generally healthy?
- Are you willing to take study medicines and have blood tests?
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 in this study, you would first have a health check to make sure you're suitable. Once enrolled, you would receive doses of obefazimod, a new medicine, and also rosuvastatin, a common cholesterol medicine. The study is split into two parts: you'll first receive a single dose of obefazimod, and then later, you'll receive multiple doses of obefazimod. Throughout these periods, you'll also be given rosuvastatin. The study team will take blood samples regularly to measure the levels of both medicines in your body. You will have several visits to the study clinic, and you might need to stay overnight for some parts of the study. The total duration of your involvement, including all visits and follow-ups, will be explained in full detail by the study team.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is ulcerative colitis?
Ulcerative colitis is a long-term condition where the large intestine (bowel) becomes inflamed, leading to symptoms like tummy pain and diarrhoea.
What is obefazimod?
Obefazimod is a new medicine being tested to treat ulcerative colitis. This study helps us understand how it works with other common medicines.
What is rosuvastatin for?
Rosuvastatin is a medicine that helps lower high cholesterol levels in your blood, which can reduce your risk of heart problems.
Why are only men included in this study?
Early studies sometimes focus on one sex to get a clear understanding of how medicines work without differences between sexes making the results harder to interpret.
Will I get any payment for taking part?
Information about any potential payment for your time and travel will be provided by the study team when you inquire about participation.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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