A Study to Test How Much BI 3034701 Gets Into the Blood in Healthy People When Given in Two Different Ways
This research study is looking for healthy adult volunteers to help test a new medicine called BI 3034701. The main goal is to find out how much of this medicine gets absorbed into the bloodstream when it's given in two slightly different forms. This is important because it helps scientists choose the best way to give the medicine for future studies and, eventually, to patients. By understanding how the body handles the medicine, we can make sure it works as effectively and safely as possible. It's a very early-stage study, meaning it's one of the first times this medicine is being given to people.
At a glance
What is this study about?
Imagine you have a new car, and you want to know if it runs better on petrol A or petrol B. This study is a bit like that, but for a new medicine called BI 3034701. We're looking at two different versions, or 'formulations', of this medicine to see how well they get into the body and bloodstream.
When you take a medicine, it needs to get into your blood to travel to where it's needed. This study specifically checks how much of the BI 3034701 actually makes it into your blood and how quickly, depending on which version you take. This information is really important for the people developing the medicine. It helps them decide which version is best to use in larger studies later on.
This is a 'Phase 1' study, which means it's one of the very first times the medicine is being tested in people, usually healthy volunteers. The aim is not to treat a condition, but simply to gather basic safety information and understand how the medicine behaves in the human body. Your participation helps pave the way for potentially useful medicines in the future.
Key takeaways
- This study is for healthy adult volunteers, aged 18 to 55.
- It's testing how a new medicine, BI 3034701, gets into the blood when given in two different ways.
- This is a very early-stage study to gather basic safety information.
- You'll have health checks and blood samples taken during your participation.
- Your involvement helps in developing future medicines.
Who may be eligible?
To join this study, you need to be a healthy man or woman between the ages of 18 and 55. We'll check your health with a full medical review, including looking at your general health, blood pressure, heart rhythm (ECG), and some blood tests. Your weight needs to be within a healthy range for your height, specifically a Body Mass Index (BMI) between 20.0 and 32.0.
If you're a woman who could become pregnant, you'll need to agree to use reliable contraception throughout the study. This is to make sure you don't become pregnant while taking part, as we don't yet know how the study medicine might affect a pregnancy.
There are also some reasons why you might not be able to join. For example, if any of your health checks show something that the study doctor thinks is important or could affect your safety, or if your blood pressure or heart rate are outside certain limits. Some specific blood test results could also mean you can't take part. These rules are put in place to keep you safe and make sure 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 between 18 and 55 years old?
- Do you consider yourself generally healthy?
- Is your weight (BMI) within the healthy range (20.0 to 32.0)?
- Are you able to use reliable contraception if you're a woman who could become pregnant?
- Are you willing to attend regular clinic visits for health checks and blood tests?
What does participation involve?
If you decide to take part, you'll first have a full health check to make sure you're suitable for the study. This includes a medical history, physical exam, blood and urine tests, and an ECG (heart trace).
If you're eligible, you'll receive the study medicine, BI 3034701, in one of two different ways, as chosen by the study team. You'll have regular visits to the clinic, where the study team will take blood samples to measure how much of the medicine is in your system. They'll also check your blood pressure, heart rate, and ask how you're feeling to monitor your safety. The exact number of visits and the total length of the study will be explained in detail by the study team. You'll be given a schedule so you know exactly what to expect.
Potential risks and benefits
Locations (1)
- Quotient SciencesVerified postcodeNottingham, United Kingdom· Recruiting
Common questions
What is BI 3034701?
It's a new medicine that is being developed. We don't know what it's for yet, as this study is just looking at how the body handles it.
Why are you testing two different ways of giving the medicine?
We want to find out which version of the medicine gets into the blood best. This helps researchers choose the most effective way to give it in the future.
Will I get paid for taking part?
Often, healthy volunteer studies offer some payment for your time and inconvenience. The study team will be able to tell you if this is the case for this study.
How long will the study last for me?
The total duration of your participation, including visits and follow-up, will be clearly explained by the study team before you agree to take part.
What if I feel unwell during the study?
The study team will monitor you closely. If you feel unwell, you should tell them straight away. Your safety is their top priority.
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?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.