Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A study in healthy people to compare how 2 different high dose formulations of BI 1015550 are taken up in the body

This study aims to understand how two different high-strength versions of a medicine called BI 1015550 behave once they're in the body. Researchers want to see if the body handles both versions in a similar way, meaning they are 'bioequivalent'. This type of study is an important first step for any new medicine. By carefully measuring how much of the medicine gets into the bloodstream and how long it stays there, scientists can make sure that future patients will receive a consistent and effective treatment. Only healthy adults are taking part, and it's a very early phase of testing new medicines.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

13 May 2024

Pharmacokinetic trial

What is this study about?

Imagine you take a paracetamol tablet. Your body breaks it down and absorbs it into your blood, where it then starts to work. This study is similar, but it's for a new medicine called BI 1015550. Researchers want to see how two slightly different, but both high-strength, versions of this new medicine are taken up by the body in healthy people.

This kind of study is called a 'pharmacokinetic trial' or 'bioequivalence study'. It's like checking that two different brands of the same ingredient deliver the same amount of that ingredient to your body. Is there more of the medicine in your blood, and for how long, when you take one version compared to the other? This is really important to ensure that when this medicine is eventually given to patients, it will always work in a predictable and consistent way, no matter which version is used.

Because this is such an early stage of testing, it’s being done in healthy volunteers. This helps researchers understand the basic information about the medicine without other health conditions getting in the way. It's a key step in developing new medicines, ensuring they are well-understood before they move on to bigger studies with people who have health conditions.

Key takeaways

This is an early-stage study for a new medicine, BI 1015550.
It's for healthy adults, aged 18 and over.
The study compares how two strong versions of the medicine are absorbed by the body.
Participation involves clinic visits and blood tests.
It helps ensure new medicines are consistent and safe for future patients.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be a healthy adult, aged 18 years or older. There is no upper age limit, as long as you meet all the other health criteria. Both men and women are welcome to take part.

Because this is a study looking at how the body handles a medicine, participants will need to be generally in good health. This means you shouldn't have any serious ongoing health conditions that could affect how your body processes the study medication or which might put you at risk. The study team will do some checks to make sure you're suitable and in good health before you can join.

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?
Are you generally in good health?
Do you have any serious ongoing medical conditions?
Are you able to commit to several clinic visits and follow-ups?
Are you comfortable with regular blood tests?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve a few visits to a clinic. You would receive one of the two different high-dose versions of the study medicine, BI 1015550. This isn't a long-term treatment, but rather a short-term assessment. Over a period of time, healthcare professionals would take blood samples to measure how much of the medicine is in your system. They might also check your vital signs like blood pressure and heart rate to make sure you're doing well. After a break, you would then likely receive the other version of the medicine, and the same measurements would be taken again. The total duration of your participation, including all visits and follow-ups, would be explained to you in detail by the study team.

Potential risks and benefits

Participating in a study like this helps advance medical science and brings new medicines closer to people who need them. While you might not directly benefit from taking part, the information gained is vital for future patients. All medicines have potential risks, and you might experience side effects from BI 1015550, some of which are unknown as it's an early study. The study team will closely monitor you and explain all known risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What does 'healthy people' mean in this study?

It means people who don't have any major ongoing illnesses or medical conditions that could interfere with how their body handles the study medicine.

What is BI 1015550?

It's a new medicine being developed. This study is part of its very early testing stages to understand its basic behaviour in the body.

Will I get paid for taking part?

Payment for participation in clinical trials varies. This will be openly discussed with you by the research team if you are eligible and interested.

How long will I have to stay at the clinic?

The study team will tell you the exact schedule, including how long each visit or stay might be. It often involves overnight stays for these types of studies.

Is this medicine for a specific illness?

Not at this stage. This study is just looking at how the medicine works in the body, not whether it treats a specific disease yet.