Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to test how BI 456906 is taken up in the blood of people with and without kidney problems

This research study is about a new medicine called BI 456906. We want to understand how it behaves in the body, specifically how it's absorbed into the blood and processed. We'll be looking at people with healthy kidneys and those with different levels of kidney problems (mild, moderate, and severe). This is an early, small study, often called a Phase 1 study, which helps us learn basic information about a new medicine. The main goal is to find out if the medicine is processed differently in people with kidney issues compared to those with healthy kidneys. This information is really important for deciding the right dose and making sure the medicine is safe and works well for everyone. Participants must be 18 years or older.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

23 Feb 2024

Renal impairment (mild moderate and severe)Healthy

What is this study about?

This study is all about a new medicine called BI 456906. Think of it like this: when you take a medicine, your body needs to absorb it, use it, and then get rid of it. Our kidneys play a big role in getting rid of medicines. If your kidneys aren't working as well as they should, it might change how your body handles a medicine, which could mean it stays in your system longer or at higher levels than intended.

That's why this study is so important. We want to see if having kidney problems changes how BI 456906 is taken up into the blood and then processed by the body. We'll be looking at people with healthy kidneys to get a baseline, and then comparing that to people who have mild, moderate, or severe kidney issues. This helps us understand if we might need to adjust the dose of this medicine for people with kidney disease in the future.

This is an early stage study, often called a 'Phase 1' study. These studies are crucial because they help us learn basic information about a new medicine, like how safe it is and how it moves through the body before it's given to many people. The information we gather will help doctors decide how best to use this medicine for different patients if it becomes available in the future.

Key takeaways

This study helps understand a new medicine, BI 456906.
It's looking at how the medicine works in people with and without kidney problems.
It's an early-stage study to gather important safety information.
Anyone aged 18 or over might be able to participate.
Participation involves taking the medicine and having health checks.

Who may be eligible?

This study is looking for adults aged 18 years or older. This means that if you are 17 or younger, you unfortunately cannot take part.

We are looking for both healthy volunteers and people who have kidney problems. If you have kidney issues, the study is interested in people with mild, moderate, or severe kidney problems. The doctors running the study will check to see if your kidney function fits what they need.

Both men and women can take part in this study. The medical team will also check your overall health to make sure it's safe for you to 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 18 years old or older?
Do you have healthy kidneys, or mild, moderate, or severe kidney problems?
Are you able to attend study visits as required?
Are you willing to take the study medicine as instructed?
Are you able to understand the study information and give your consent?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have some health checks to make sure you are suitable. This might involve blood tests, a physical exam, and checking your kidney function. If you qualify, you would be given the study medicine, BI 456906, likely as a tablet or capsule.

You would need to attend several visits to the study clinic. During these visits, doctors and nurses would monitor your health and take blood samples to see how the medicine is moving through your body. There might be a short stay at the clinic or hospital, or it might involve appointments spread out over time. The total duration of your participation, including all visits and any follow-up, would be explained to you in detail.

Potential risks and benefits

Participating in any study has potential benefits and risks. A potential benefit of this study is that you would be contributing to medical science, which could help future patients. You might also have close medical monitoring during the study period. However, there are potential risks, such as side effects from the study medicine, discomfort from blood tests, or inconvenience from clinic visits. There is no guarantee that taking part will directly improve your health. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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 is BI 456906?

It's the name of a new medicine that is being studied. We are trying to learn more about how it works in the body.

Why are you studying people with kidney problems?

Because kidneys help remove medicines from the body. We want to see if having kidney problems changes how this new medicine is handled, so we can give the right dose in the future.

What happens in a 'Phase 1' study?

These are early studies to learn basic information about a new medicine, like how safe it is and how the body handles it, before it's given to many people.

Will I get paid to take part?

This would be discussed with you by the study team. Sometimes participants are reimbursed for their time and travel, but this varies.

What if I change my mind after joining?

You can leave the study at any time, for any reason, and it won't affect your regular medical care. Your decision is always respected.