Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A study in healthy people to see how zongertinib is taken up into the blood when given as tablets made by two different manufacturers

This study is for healthy people and is testing a new medicine called zongertinib. Researchers want to compare two slightly different versions of the zongertinib tablet, made by different companies, to see how each one gets into the bloodstream. This is important to make sure that people will get the right amount of medicine if it becomes widely available. By understanding how the body uses each version, scientists can choose the best and most consistent way to deliver this potential new treatment. This type of study is an early step in developing new medicines.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

05 Apr 2024

Healthy volunteer trial

What is this study about?

Imagine you have a new medicine, but it can be made into a tablet in slightly different ways. This study wants to find out which way is best for a medicine called zongertinib. They are comparing two different tablets of zongertinib, made by different manufacturers, to see how your body takes in the medicine from each one. They do this by measuring the amount of zongertinib in your blood after you take the tablets.

The main goal is to make sure that if zongertinib is used in the future, people will always get the same amount of medicine working in their body, no matter which manufacturer makes the tablet. This is called 'bioequivalence' – it just means checking if two versions of a medicine are basically the same in how they act inside you. This is a very important step to ensure any new medicine is safe and effective before it can be used more widely.

Because this is an early study with a new medicine, it's being done with healthy volunteers. This helps researchers understand how the medicine behaves in people who don't have any other health conditions. Your participation helps pave the way for new potential treatments.

Key takeaways

This study is for healthy volunteers, not for treating an illness.
It compares how two versions of a new medicine, zongertinib, enter the bloodstream.
This helps ensure future zongertinib medicines are consistent and work properly.
Both men and women aged 18 and older can participate.
Your participation helps develop new medicines for the future.

Who may be eligible?

This study is looking for healthy adults. You can join if you are 18 years old or older – there's no upper age limit, as long as you are considered healthy overall.

Both men and women are welcome to take part in this research. The most important thing is that you are in good health. This means you shouldn't have any ongoing medical conditions that could make taking the study medicine risky or change how your body handles it.

Before you can join, the study team will ask you some questions about your health and might do a basic health check-up to make sure this study is right and safe for you.

Quick self-check

Are you 18 years old or older?
Are you generally in good health?
Do you not have any serious ongoing medical conditions?
Are you able to attend clinic visits as required?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you will likely visit the clinic regularly. During these visits, you will be given one of the zongertinib tablets. Blood samples will be taken at different times after you take the medicine to see how much of it is in your body. This helps researchers compare the two different tablet versions.

You might also have other assessments, like health checks, vital signs (like blood pressure and heart rate), and perhaps answer questions about how you are feeling. You would take study medication for a limited period, and there might be follow-up calls or visits after you've finished taking the tablets to make sure you're doing well. The total time you spend in the study, from first screening to final follow-up, will be explained in detail.

Potential risks and benefits

Participating in research can offer the satisfaction of contributing to medical science and helping develop new treatments for others. However, like all medicines, zongertinib could have side effects, even in healthy people. The study team will explain any known or potential mild or serious side effects you might experience. You will also have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Germany

Common questions

What is zongertinib?

Zongertinib is a new medicine that is being studied. Its exact purpose isn't the focus of this particular study, which is just looking at how the body absorbs it.

Why are you testing two different tablets?

We are comparing two slightly different versions of the zongertinib tablet, made by different companies, to see how well they are absorbed by the body. This helps ensure that any future medicine is consistent and effective.

Do I need to have a specific illness to join?

No, this study is for healthy volunteers. You don't need to have any particular health condition to take part.

Will I know which tablet I'm taking?

The study team will explain how the tablets are given. Sometimes participants might not know which tablet they receive to keep the study fair, but you'll be fully informed about the study design.

How long will I be involved in the study?

The exact duration of your participation will be fully explained by the study team, including screening, dosing periods, and follow-up visits.