A Phase I study to evaluate the pharmacokinetics, safety and tolerability of multiple oral doses of obefazimod in participants with renal impairment and matched normal kidney function.
This research study is testing a new medicine called obefazimod. It's for people who have moderately to severely active ulcerative colitis. The main goal is to understand how the body processes this medicine when taken several times. Researchers want to see if it behaves differently in people who have some kidney problems compared to those with perfectly healthy kidneys. They will also be carefully monitoring for any side effects to make sure the medicine is safe. This is an early stage study (Phase I) that helps doctors learn more about new medicines before they are tested in larger groups of people, ensuring future studies can be as safe and effective as possible.
At a glance
What is this study about?
This study is about a new medicine called obefazimod, which is being developed to help people with ulcerative colitis. Ulcerative colitis is a long-term condition where the lining of the large intestine (colon) becomes inflamed, causing symptoms like tummy pain, diarrhoea, and blood in your poo. The medicine, obefazimod, isn't widely available yet, so this study is an important step in learning more about it.
In this early study, researchers want to see how the body handles obefazimod. They're especially interested in how it's processed and cleared from the body (which is called 'pharmacokinetics') when people take it more than once. A key part of this study is to compare how the medicine works in people who have some issues with their kidneys versus those whose kidneys are working normally. This information is vital because kidneys often play a big role in removing medicines from the body.
By carefully studying how obefazimod behaves in different people, and by keeping a close eye on any side effects, scientists can learn if it's safe and how it might need to be adjusted for people with kidney problems in the future. This kind of research is crucial for making sure that new medicines can be safely used by as many people as possible who might benefit from them.
Key takeaways
- This study tests a new medicine called obefazimod for ulcerative colitis.
- It's an early-stage study focusing on medicine safety and how the body processes it.
- Researchers are comparing how the medicine works in people with and without kidney problems.
- Participants must be 18 years or older.
- Your contribution could help develop future treatments for ulcerative colitis.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Currently, we don't have very detailed information about other specific health conditions or medications that might prevent someone from joining. However, studies like this often look for people with a specific health issue, in this case, moderately to severely active ulcerative colitis, and then compare them with people who don't have that condition.
Before you can join, a study doctor will carefully check your health and medical history to make sure the study would be safe for you and that you meet all the requirements. They will explain everything in detail.
- Are you 18 years old or older?
- Do you have moderately to severely active ulcerative colitis?
- Are you able to take medicine by mouth (orally)?
- Are you willing to attend regular clinic visits and have blood/urine tests?
- Are you prepared to potentially have kidney function 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 be taking the new medicine, obefazimod, by mouth multiple times. This is a Phase I study, which means it's an early look at the medicine's safety and how your body processes it. You would have regular visits to the study clinic, where doctors and nurses would perform various assessments. These assessments would likely include blood tests to check how the medicine is working and how your body is reacting, as well as urine tests. They would also monitor your overall health, ask about any side effects you might experience, and record your vital signs like blood pressure and heart rate. You would receive careful instructions on how to take the medicine and what to expect. The total duration of your participation, including how many visits and follow-ups, would be fully explained by the study team.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is ulcerative colitis?
Ulcerative colitis is a long-term condition where the lining of your large intestine (colon and rectum) becomes inflamed and develops small sores, leading to symptoms like tummy pain and urgent bowel movements.
What does 'Phase I study' mean?
Phase I is the first step of testing a new medicine in people. It mainly checks if the medicine is safe, what the right dose might be, and how the body handles it. It usually involves a small number of participants.
What are 'kidney problems' in this study?
This study is looking at people with moderately impaired kidney function, meaning their kidneys don't work quite as well as healthy ones, but are not yet severely ill. They will compare them to people with normal kidney function.
Will I get the actual medicine or a dummy pill (placebo)?
This study focuses on understanding how the body handles the medicine, so it's likely that all participants in the active groups will receive obefazimod. The study will not include a placebo group.
Will I have to pay to be in the study?
No, you will not have to pay to participate in this research study. All study-related care and medicine will be provided free of charge.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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