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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy men to test whether zongertinib influences the amount of 3 other medicines in the blood

This study is for healthy men and is designed to find out how a new medicine, zongertinib, interacts with three other common medications in the body. Researchers want to see if taking zongertinib changes the amount of these other medicines found in the blood. This kind of research is important because it helps doctors and scientists understand how different medicines work together, or if they might affect each other. This information is key to making sure new medicines are safe and work effectively when people take them with other prescriptions.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Boehringer Ingelheim International GmbH
Enrolment target
16
Start
29 May 2024

What is this study about?

Imagine your body as a busy factory, processing everything you put into it, including medicines. This study is like sending a new supervisor, zongertinib, into the factory and watching to see if it changes how three other workers (other medicines) do their jobs. Specifically, researchers want to see if zongertinib makes the levels of these other medicines in your blood go up, go down, or stay the same.

This type of study is called a 'pharmacokinetic trial,' which is just a scientific way of saying we're studying how the body handles medicines – how it absorbs them, distributes them, changes them, and gets rid of them. It's a very early-stage study, meaning it's one of the first times this new medicine is being given to people. This helps us gather important safety information before it's given to a wider group of people or those with specific health conditions.

The main goal is to understand potential medicine interactions. This knowledge is incredibly important for doctors. If a new medicine affects how other drugs work, doctors need to know so they can adjust dosages or choose different medicines to keep you safe and ensure all your treatments are effective. It's all about making sure medicines work well together.

Key takeaways

  • This study helps understand how a new medicine (zongertinib) interacts with other common drugs.
  • It's for healthy adult men.
  • The main goal is to check how medicine levels change in the blood.
  • It's an early-stage safety study.
  • Participants contribute to future medicine safety and development.

Who may be eligible?

This study is specifically looking for healthy volunteers. To take part, you must be a man.

There are no age limits mentioned beyond being an adult. This means that if you are 18 years old or older, you could potentially be eligible. You would not be able to join if you are a woman.

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.

  1. Are you a man?
  2. Are you 18 years old or older?
  3. Are you generally healthy?
  4. Are you willing to take study medications?
  5. Are you comfortable providing blood and urine samples?
Answer every question to see your result.

What does participation involve?

While the detailed description wasn't provided, typically for this type of early-stage study, you would likely: attend several visits to a clinic or research facility; provide blood and possibly urine samples; take the study medicine (zongertinib) and the three other medicines being tested; and undergo health checks, including blood pressure and heart rate measurements. The total duration of your involvement could range from a few weeks to a few months, including follow-up appointments.

Potential risks and benefits

The potential benefits are indirect; you would be contributing valuable information that could help develop safer and more effective medicines for others in the future. As with any new medicine, there might be unknown risks, and you could experience side effects from zongertinib or the combination of medicines. All known risks would be fully explained before you agree to take part. You would always 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.
  • Unverified
    Germany

Common questions

What does 'pharmacokinetic' mean?

It's a medical term for how your body handles a medicine – how it absorbs it, moves it around, changes it, and gets rid of it.

Why is this study only for men?

Early studies sometimes focus on one sex to understand how a medicine works without the added complexities that can come from differences between men and women's bodies. Once it's safer, women may be included in later studies.

Will I get paid for taking part?

Study participation for healthy volunteers often includes some payment for your time, effort, and travel expenses. This would be explained in detail if you are interested in joining.

What if I feel unwell during the study?

A team of doctors and nurses would carefully monitor you throughout the study. If you felt unwell, they would be there to help and provide any necessary medical attention.

Is zongertinib a new medicine?

Yes, it is being tested in humans for the first time, or very early on, to understand its effects better.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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