Phase I, Open-Label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of BIA 28-6156 in Participants with Varying Degrees of Renal Impairment
This Phase 1 clinical trial is looking at an experimental medicine called BIA 28-6156, which is being developed to treat Parkinson's disease. Before a new drug can be widely used, doctors must understand how the body breaks it down and removes it. Because the kidneys play a major role in filtering medicines out of the blood, this study focuses on how people with varying levels of kidney function handle the drug. Participants will take BIA 28-6156 while doctors closely monitor their health, side effects, and blood levels of the drug. The study is open-label, meaning both the participants and the medical team know which medicine is being taken. The results will help researchers determine safe and effective doses for future patients who may also have kidney problems.
At a glance
What is this study about?
Parkinson's disease is a condition that affects the brain and causes movement problems, such as tremors, stiffness, and balance issues. Scientists are continuously working to develop new medications to help manage Parkinson's symptoms or slow down how quickly the condition changes. One experimental drug currently being tested is called BIA 28-6156.
When you take any medicine, your body must process it and eventually clear it away. For many drugs, the kidneys do the heavy lifting by filtering the medicine out of the bloodstream and passing it into urine. If someone has reduced kidney function, a drug might stay in their body for longer than usual, which could increase the chance of side effects. That is why it is vital to test new medicines in people with different levels of kidney health.
This study is a Phase 1 clinical trial. These early studies focus heavily on safety. Researchers will measure drug levels in blood and urine samples over time to see exactly how quickly BIA 28-6156 is absorbed and removed. The trial is 'open-label', which means no dummy pills (placebos) are used, and everyone involved knows what dose is being given.
By taking part, participants provide important scientific information. This helps researchers figure out if the dosage of BIA 28-6156 needs to be adjusted for people whose kidneys do not work at full strength, making future treatments safer for everyone.
Key takeaways
- Phase 1 trial testing how the investigational Parkinson's drug BIA 28-6156 is processed by the body.
- Aims to understand how different levels of kidney function affect how the drug is cleared.
- Open to adults aged 18 and older with varying stages of kidney health.
- Involves detailed health monitoring, including regular blood and urine tests.
- Participation is entirely voluntary, and you can leave the study at any time.
Who may be eligible?
This trial is open to adults aged 18 and older. Researchers are looking for people with different degrees of kidney function, ranging from healthy kidneys to mild, moderate, or more severe kidney problems. Both men and women may be able to join.
To take part, volunteers will need to undergo standard medical checks. These checks ensure that it is safe for them to receive the study drug and that their kidney condition meets the specific categories the researchers are studying.
People might not be eligible if they have certain other unstable medical conditions, active infections, or take specific prescription medications that could interfere with the study drug. A doctor from the trial team will review each person's full medical history before they can join.
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.
- You are aged 18 years or older.
- You are willing to attend appointments and possibly stay overnight at the study clinic.
- You have either normal kidney function or known kidney problems.
- You are happy to have regular blood tests, urine tests, and health checks.
- You can provide a list of all your current medications to the research team.
What does participation involve?
Taking part in this study involves visiting a specialist clinical trial unit. At the start, you will have screening tests, such as blood tests, urine tests, heart traces (ECGs), and a physical examination to check your general health and kidney function. If eligible, you will receive a dose of BIA 28-6156. The study may require an overnight stay or several daytime visits so the team can monitor you closely. Staff will take regular blood and urine samples over several hours or days to measure how the medicine moves through your body. You will also have follow-up checks to make sure you have recovered well and to see if you experienced any side effects. The study team will explain the exact number of visits and overall duration before you decide to join.
Potential risks and benefits
Locations (1)
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Common questions
What is BIA 28-6156?
BIA 28-6156 is an experimental drug being researched to see if it can help treat Parkinson's disease. It is not yet available as a regular prescription.
What does 'open-label' mean?
It means that both you and the researchers will know that you are receiving the active study medicine. There is no fake pill or placebo in this study.
Do I need to have Parkinson's disease to join?
Not necessarily. Phase 1 kidney studies often look for volunteers based primarily on their kidney function rather than whether they have the condition the drug is meant to treat. The study team can confirm specific requirements.
Will taking part cost me anything?
Clinical trials generally provide the study drug and all trial-related tests free of charge. Most trials also reimburse reasonable travel and meal expenses.
Can I stop taking part if I change my mind?
Yes. You have the right to withdraw from the study at any time, for any reason, and your regular NHS medical care will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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