A Clinical Study to Compare the Impact of Multiple-dose Oral Administration of Macitentan, 10 mg versus 75 mg on Endothelin-1 Clearance, Endothelial Function, and Hemodynamics in Healthy Participants
This study is looking at a medicine called macitentan, which is used to treat a serious lung condition. The aim is to understand how different amounts (doses) of this medicine affect healthy people. Researchers want to see how the body deals with the medicine and if it changes how successfully the body clears a natural substance called endothelin-1. They are also checking how the medicine affects the health of blood vessels, specifically the lining of these vessels, and blood flow. This is a very early stage (Phase I) study, meaning it's focused on learning about the medicine's basic effects and safety in people, rather than testing if it treats a specific illness. It helps scientists learn more about new drugs before they can be given to patients who need them.
At a glance
What is this study about?
This research study is about a medicine called macitentan. This medicine is already used to help people with a condition called pulmonary arterial hypertension. This condition makes the blood vessels in the lungs narrow, making it hard for the heart to pump blood, and causing breathlessness and tiredness. However, this particular study is not testing the medicine to treat that condition.
Instead, this study is taking place in healthy volunteers. The main goal is to understand how the body handles different doses (amounts) of macitentan. Researchers are specifically interested in how well the body clears a natural substance called endothelin-1, which can affect blood vessel narrowing. They also want to see if the medicine changes how healthy the lining of your blood vessels is, and how it affects blood flow. This information is really important for developing medicines safely and understanding how they work.
By carefully studying how macitentan works in healthy people, scientists can gain crucial insights. These insights help them decide the best doses for future studies and understand potential effects of the medicine. This early research is a vital step in making sure that medicines are as safe and effective as possible for patients who need them.
Key takeaways
- This study tests a medicine called macitentan in healthy adults.
- It aims to understand how the body handles different doses of the medicine.
- Researchers are looking at effects on endothelin-1 and blood vessel health.
- This is an early-stage study (Phase I) for general understanding, not treatment.
- Participation involves taking the medicine and having regular health checks.
- There is no direct health benefit for participants, but you contribute to medical research.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
It's important that you are generally healthy. This means that you shouldn't have any major ongoing health problems or be taking medicines that could interfere with the study drug.
Before you can join, the study team will ask you questions about your health and may do some checks to make sure you are a good fit for this early stage research. This is to keep you safe and ensure the study results are clear.
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 with no serious ongoing medical conditions?
- Are you able to attend several appointments at a clinic or hospital?
- Are you willing to take an oral study medicine as instructed?
- Are you comfortable having blood tests and other health checks?
What does participation involve?
If you decide to take part, you will be given macitentan medicine by mouth for a short period. The study team will decide which dose you receive. During this time, and at specific points before and after, doctors and nurses will monitor your health carefully. This will likely involve regular check-ups, blood tests, and possibly other tests to measure things like blood flow and how your body clears substances. The exact number of visits and tests will be explained to you in detail, but expect multiple visits to the clinic or hospital. The entire study, from start to finish, will have a set duration, which you will be told upfront.
Potential risks and benefits
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Common questions
What is macitentan used for normally?
Macitentan is a medicine used to treat a serious condition called pulmonary arterial hypertension, which affects the blood vessels in the lungs.
Why are healthy people taking part if it's for a lung condition?
This early-stage study in healthy people helps researchers understand how the medicine works in the body and its basic effects before it's tested more widely in patients with the condition.
Will I get the medicine that helps my health?
No, this study is not designed to treat a disease, and there is no direct health benefit for you from taking the medicine. You are helping science.
What does 'Phase I' mean?
Phase I is the first step in testing a new medicine in people. It mainly focuses on how the drug is handled by the body, its basic effects, and its safety in a small group of healthy volunteers.
Do I have to pay to join the study?
No, you do not have to pay to participate. Any study-related care and medicines will be provided by the research team.
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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