A single-dose, open-label study of TX000045 in patients with CpcPH or IpcPH and HFpEF.
This research is investigating a new medicine, TX000045, for individuals who have a specific form of high blood pressure in their lungs, known as pulmonary hypertension, particularly when it's linked with heart failure. The study is a very early step, often called a 'Phase 1' study. Its main aim is to understand how a single dose of TX000045 behaves in the human body, for example, how much ends up in the bloodstream and how long it stays there. This helps researchers figure out if the medicine is safe enough to study further and how the body handles it. It's open to adults aged 18 and over, both men and women.
At a glance
What is this study about?
This study is about a new medicine called TX000045. It's being tested for people who have a condition where the blood pressure in the arteries leading from the heart to the lungs is too high. This is called pulmonary hypertension. More specifically, the study is looking at two types of this condition: one where both the smaller and larger blood vessels in the lungs are affected, and another where mainly the larger vessels are involved. These types of pulmonary hypertension can sometimes happen alongside a kind of heart failure where the heart struggles to fill with enough blood, but it can still pump blood out with good force.
Because this is an early study, often called a 'Phase 1' study, the main goal isn't to see if the medicine treats the condition in the long term. Instead, it's about understanding the basics of how TX000045 works in the human body. Researchers want to find out how much of the medicine gets into the bloodstream, how it's handled by the body, and how long it stays there after someone takes a single dose. This information is really important for deciding if the medicine is safe enough to continue studying and to help plan future research.
Understanding these basic facts about TX000045 is a crucial step in developing new treatments. If the medicine shows promise and is well-tolerated in this early phase, it could move on to larger studies to see if it can effectively help people with these specific types of lung high blood pressure and heart failure. It offers a chance to explore new ways to manage these challenging conditions.
Key takeaways
- This study is testing a new medicine (TX000045) for specific types of high lung blood pressure and heart failure.
- It's a very early-stage (Phase 1) study focused on safety and how the medicine behaves in the body after one dose.
- You must be 18 or older to take part, and further health checks will confirm if you are eligible.
- Participation involves taking a single dose of medicine and close monitoring by the study team.
- There are potential benefits like close medical care, but also risks as the medicine is new.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women are welcome to take part.
There will be other important checks to make sure the study is right for you and that you meet all the necessary health requirements. For example, the study is specifically looking for people who have been diagnosed with certain types of high blood pressure in their lungs (pulmonary hypertension) and a specific kind of heart failure. Your medical history and overall health will be carefully reviewed by the study team.
Because this is an early study of a new medicine, there will likely be very specific health criteria to ensure your safety. This includes things like the specific type and severity of your condition, other conditions you might have, and any other medicines you are currently taking. The study team will discuss all of these details with you.
- Are you 18 years old or older?
- Have you been diagnosed with high blood pressure in your lungs (pulmonary hypertension)?
- Do you also have a type of heart failure where your heart struggles to fill with blood but can pump it with good force?
- Are you able to attend all study visits and appointments?
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, you would receive a single dose of the study medicine, TX000045. As this is an early-stage study, you would likely need to stay at a special research clinic or hospital unit for a period of time after taking the medicine. This is so the research team can carefully monitor your health and how your body reacts to the medicine.
During your participation, you would have several assessments. These might include blood tests to check how the medicine is processed by your body, heart checks, and other general health checks to make sure you are feeling well. The total duration of your active participation will depend on the monitoring schedule, but for a single-dose study, it's typically for a shorter period, possibly a few days, followed by some follow-up checks. All details about visits, tests, and the exact length of your involvement would be explained to you before you agree to take part.
Potential risks and benefits
Locations (1)
- —Netherlands
Common questions
What is pulmonary hypertension?
It's a condition where the blood pressure in the arteries that go to your lungs is too high. This makes your heart work harder.
What does 'single-dose' mean?
It means you would only take the study medicine once. Researchers then observe how your body reacts to that single dose.
What does 'Phase 1' mean for a study?
It's the first stage of testing a new medicine in people. The main goal is to check its safety and how the body handles it, rather than if it treats the condition long-term.
Will this medicine help my condition?
The main goal of this early study is to understand how the medicine works in the body and its safety. It's not designed to test if it will treat your condition effectively just yet.
Do I have to pay to join the study?
No, you should not have to pay to participate in a clinical trial. Any study-related care and medicines are typically 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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