A Study in Healthy People to Test How Vicadrostat Affects the Heart
This research study is called 'A Study in Healthy People to Test How Vicadrostat Affects the Heart.' It's a Phase 1 trial, which means it’s one of the first times this new medicine, Vicadrostat, is being given to people. The main goal is to understand how Vicadrostat might affect your heart. Researchers will compare Vicadrostat with a 'placebo,' which is a dummy pill that looks like the real medicine but contains no active ingredients. Another medicine called Moxifloxacin will also be used as a comparison in some participants. This helps the researchers see if Vicadrostat has any specific effects on the heart that are different from not taking any active medicine or from taking a medicine with known heart effects. The study is gathering important safety information in healthy volunteers aged 18 to 50.
At a glance
What is this study about?
Imagine scientists have developed a new medicine called Vicadrostat. Before it can be given to people who are unwell, they need to make sure it's safe and understand how it works in healthy individuals. That's exactly what this study is about. It's a Phase 1 clinical trial, which means it’s one of the very first steps in testing a new medicine.
The main purpose of this study is to carefully watch how Vicadrostat might affect your heart. Researchers will compare people taking Vicadrostat with others taking a 'placebo' – a dummy pill that looks identical but has no active ingredients. This helps them see if any changes are truly due to Vicadrostat. They will also look at a known medicine called Moxifloxacin to help them understand the heart's response.
By including healthy volunteers, researchers can get a clear picture of Vicadrostat's effects without other health conditions making it difficult to understand the results. This is a crucial step to ensure future safety and to help decide if Vicadrostat should be studied further for treating specific illnesses.
Key takeaways
- This is a Phase 1 study testing a new medicine called Vicadrostat.
- The main goal is to check how Vicadrostat affects the heart in healthy people.
- Participants will receive either Vicadrostat, a dummy medicine (placebo), or Moxifloxacin.
- You need to be a healthy adult aged 18-50 to be considered.
- Taking part will involve medical checks, blood tests, and heart tracings (ECGs).
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you need to be a healthy man or woman between 18 and 50 years old, including your 18th and 50th birthdays. Your weight should also be within a healthy range for your height, meaning your Body Mass Index (BMI) needs to be between 18.5 and 29.9. Before you can join, a doctor will check your overall health, including a physical exam, your blood pressure, pulse, and an heart tracing (ECG), as well as some blood and urine tests.
You won't be able to take part if you have any health issues that the study doctor thinks are important, or if your blood pressure, pulse, or heart tracing results are outside of a normal range. You also can't join if any of your blood or urine test results are unusual in a way the doctor believes is significant. Having any other ongoing illness that the doctor considers important would also mean you can't participate.
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 generally healthy?
- Are you between 18 and 50 years old?
- Is your weight (BMI) in the healthy range (18.5-29.9)?
- Do you have any significant ongoing health conditions?
What does participation involve?
If you decide to take part, you'll first have a screening visit to check if you're suitable for the study. This will involve examinations and tests. If you meet all the criteria, you will then be randomly assigned to receive either Vicadrostat, a placebo (dummy medicine), or Moxifloxacin. You won't know which one you are taking.
Throughout the study, you will have several visits to the clinic where doctors and nurses will monitor your health very closely, especially your heart. This will involve regular medical checks, taking your vital signs (like blood pressure and pulse), having more heart tracings (ECGs), and taking blood and urine samples. The total duration of your involvement in the study, from your first screening visit to your final follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- Humanpharmakologisches Zentrum BiberachVerified postcodeBiberach, Germany· Recruiting
Common questions
What is Vicadrostat?
Vicadrostat is a new medicine that is being tested. Scientists want to understand how it works and whether it is safe.
What is a Phase 1 study?
A Phase 1 study is one of the first steps in testing a new medicine in people. It mainly focuses on safety and how the body handles the medicine in healthy volunteers.
What is a placebo?
A placebo is a 'dummy' pill or treatment that looks exactly like the real medicine but contains no active ingredients. It helps researchers see if the real medicine is actually having an effect.
Will I know if I'm getting Vicadrostat or the dummy medicine?
No, in this study, neither you nor the study team will know whether you are receiving Vicadrostat, the placebo, or Moxifloxacin. This helps ensure unbiased results.
What happens if I change my mind?
You are free to leave the study at any time, for any reason, without needing to explain why. Your decision will not affect your future medical care.
How to find out more
Boehringer Ingelheim
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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