Impact of Multiple Doses of BAY63-2521 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Patients With Interstitial Lung Disease (ILD) Associated Pulmonary Hypertension (PH)
This research study is for people who have a condition called "pulmonary hypertension" (high blood pressure in the lungs) that is linked to a lung disease called "interstitial lung disease" (ILD). The study is testing a new medicine, BAY63-2521. It's an early-stage study, meaning researchers want to learn if the medicine is safe, how well people tolerate it, and how the body uses and reacts to it. The main goal is to understand if this new treatment could help improve the health of people with these conditions. It's important to know that this is a therapeutic exploratory (Phase II) study, which means it's still in the early stages of finding out if the medicine works.
At a glance
What is this study about?
This study is focused on a health problem where the blood pressure in the arteries of your lungs becomes too high. This is called pulmonary hypertension (PH). In this particular study, the high blood pressure in the lungs is specifically linked to another lung condition called interstitial lung disease (ILD). ILD is a group of diseases that cause scarring in your lungs, making it harder to breathe.
Researchers are testing a new medicine called BAY63-2521. They want to carefully check a few important things: first, is it safe for people to take? Second, how well do people tolerate it – meaning, does it cause unpleasant side effects? Third, they want to understand how the body deals with the medicine (how it’s absorbed, used, and removed), and finally, whether it has any positive effects on the body (what doctors call pharmacodynamics).
Because this is a Phase II study, it means the medicine is still in relatively early stages of testing. The purpose is not yet to prove it's a cure, but rather to gather important information that will help doctors decide if it's promising enough to study further in larger groups of people. Finding new ways to help people with these conditions is very important.
Key takeaways
- Study is for high blood pressure in the lungs linked to lung scarring.
- Testing a new medicine called BAY63-2521.
- Focus is on safety, how the body uses it, and its effects.
- It's an early-stage (Phase II) research study.
- Open to adults aged 18 and over, both men and women.
Who may be eligible?
This study is looking for adults who are 18 years old or older. There is no upper age limit, meaning older adults can also take part. Both men and women are welcome to participate in the study.
The most important thing is that you must have high blood pressure in your lungs (pulmonary hypertension) that is connected to a specific kind of lung scarring disease called interstitial lung disease (ILD). If you don't have both these conditions, this particular study might not be right for you.
There will be other conditions or health factors that the study doctors will check to make sure the study is a good fit for you and safe. Only the study team can confirm if you are eligible after a careful review of your health.
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?
- Have you been diagnosed with high blood pressure in your lungs (pulmonary hypertension)?
- Is your pulmonary hypertension linked to another lung condition called interstitial lung disease (ILD)?
- Are you willing and able to attend regular hospital or clinic visits?
- Are you happy to take a new, experimental medicine?
What does participation involve?
If you decide to take part in this study, you will be given the experimental medicine, BAY63-2521, as directed by the study doctors. You will need to attend regular visits to the hospital or clinic so the study team can carefully monitor your health. These visits will likely include physical examinations, blood tests, heart and lung function tests, and possibly other scans or assessments to see how you are responding to the medicine and to check for any side effects.
The study will involve taking the medicine for a set period, and there will be follow-up appointments even after you finish taking the treatment to check on your progress and safety. The total length of your participation, including all visits and follow-up, will be explained in detail by the study team, but it could last several months.
Potential risks and benefits
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Common questions
What is 'pulmonary hypertension'?
It's a condition where the blood pressure in the arteries of your lungs is too high, making your heart work harder.
What is 'interstitial lung disease'?
It's a group of lung conditions that cause scarring and stiffness in the lungs, making it difficult for them to work properly.
What does 'Phase II' mean for a clinical trial?
It means the medicine is being tested in a small group of people to see if it's safe and if it has any effects, before it's tested in larger groups.
Will I definitely get the new medicine?
Yes, in this type of study, all participants receive the active treatment being tested.
Who is paying for this study?
The study is sponsored by a pharmaceutical company, likely the maker of BAY63-2521.
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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