A Phase 1, open label, randomised, 2-period, 2 sequence, 7-days repeat-dosing, crossover oral pharmacokinetic trial comparing multiple dosing of CS014 to valproic acid in healthy adults.
This study is testing a new medicine called CS014. It's for people with lung and heart diseases where blood clots form, blood vessels change, and tissue becomes scarred. The study is particularly interested in how the body handles CS014 compared to an existing medicine called valproic acid. Healthy adults will take CS014 and valproic acid for a few days to see how each medicine moves through and leaves their body. This helps researchers understand how CS014 might work and if it could be a useful treatment in the future. It’s an early-stage study, meaning it’s one of the first times this new medicine is being tested in people.
At a glance
What is this study about?
This study is exploring a new medicine, which we're calling CS014 for now. We know that some serious lung and heart diseases can cause problems like blood clots forming, changes in the walls of blood vessels, and scarring of tissues. These issues can make it very hard for people to breathe and can put a strain on their heart.
Researchers want to understand how CS014 works in the human body. To do this, they are comparing it side-by-side with a medicine that's already well-known, called valproic acid. By doing this comparison, they hope to learn how quickly CS014 gets into the bloodstream, how long it stays there, and how the body breaks it down and gets rid of it. This information is really important for deciding if CS014 could eventually become a helpful treatment for these serious conditions.
This is an early-stage study, sometimes called a "Phase 1" study. This means it's one of the very first times this medicine is being given to people. The main goal at this stage is to learn about how the medicine behaves in the body and to check its safety, rather than to see if it cures a disease. By taking part, healthy volunteers help us learn vital information that could lead to new treatments for serious lung and heart conditions in the future.
Key takeaways
- This study tests a new medicine (CS014) for severe lung and heart conditions.
- It aims to understand how CS014 works in the body compared to another medicine.
- The study involves healthy adults aged 18 and over, both men and women.
- Participants will follow a specific schedule of taking medicines and attending clinic visits.
- Your contribution could lead to better treatments for future patients.
Who may be eligible?
This study is looking for healthy adults. If you are 18 years old or older, you might be able to take part. There is no upper age limit for volunteers in this particular study.
Both men and women are welcome to participate. The study is designed to include a wide range of healthy adults to get a good understanding of how the new medicine works in different people.
Because this is a study for healthy individuals, people with existing heart, lung, or other serious health problems would likely not be able to join. The aim is to see how the new medicine works in a body without other health conditions affecting it.
- Are you 18 years old or older?
- Are you generally in good health?
- Are you a man or a woman?
- Are you able to attend clinic visits regularly for blood tests?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would first have a health check-up to make sure you are suitable. You would then be asked to take the study medicine, CS014, and also the comparison medicine, valproic acid, at different times. This means you would take one medicine for a few days, then have a break, and then take the other medicine for a few days.
During your time on the study, you would need to visit the study clinic regularly. These visits would involve having blood samples taken to measure the medicine levels in your body. You might also have other routine health checks such as blood pressure and heart rate measurements. The total duration of your participation, including all visits and follow-ups, would be explained to you in detail before you decide to take part.
Potential risks and benefits
Locations (1)
- —Sweden
Common questions
What does 'Phase 1' mean?
Phase 1 means it's an early study, usually the first time a new medicine is given to people, mostly to check safety and how the body handles it.
Why are healthy people needed for this study?
Healthy volunteers help researchers understand how the medicine behaves in a body without other health conditions, which is crucial for early testing.
How long will I have to take the medicine?
You'll take each medicine (CS014 and valproic acid) for about 7 days, with a break in between, as part of a crossover plan.
What is 'valproic acid'?
Valproic acid is an existing medicine that is being used in this study for comparison purposes to understand the new medicine better.
Will I know if I'm taking the new medicine or the comparison medicine?
Yes, this is an 'open label' study, meaning both you and the study team will know which medicine you are taking at which time.
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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