Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Assessment of the exposure-dependent perpetrator characteristics of metamizole on metabolic pathways and the pharmacokinetics of imatinib in healthy volunteers

This early-stage study, known as Phase I, is checking how a painkiller called metamizole interacts with another medicine, imatinib, in healthy adult volunteers. Researchers want to understand if metamizole changes how the body breaks down and uses imatinib. They are particularly interested in how different amounts of metamizole might affect these processes. This kind of research helps doctors understand how to prescribe medicines more safely and effectively in the future, ensuring patients get the right amount of their medication.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Universitaetsklinikum Heidelberg AöR

Enrolment target

Start

02 Sep 2024

Pharmacokinetic trial in healthy volunteers

What is this study about?

This research study is focused on understanding how certain medicines interact with each other within the body. Specifically, it's looking at a pain relief medication called metamizole and a different type of drug called imatinib. Imatinib is often used to treat certain cancers and other conditions.

The main goal of the study is to see if taking metamizole affects how your body processes and uses imatinib. When you take a medicine, your body has ways of breaking it down and getting rid of it. This study wants to find out if metamizole changes these processes for imatinib, and if the amount of metamizole you take makes a difference. This kind of information is really important because it helps doctors understand how to give medicines safely and ensure they work properly.

This is a very early-stage study, sometimes called a 'Phase I' study. This means it's one of the first times a specific drug interaction is being looked at in healthy people. The information gathered from studies like this helps build a foundation of knowledge for all future medical treatments, leading to safer and more effective care for everyone.

Key takeaways

Study looks at how painkiller metamizole affects imatinib.
Aims to understand drug interactions for safer medicine use.
Only healthy volunteers aged 18 and over can participate.
Involves taking medicines and having blood tests.
Helps improve future medical treatments.

Who may be eligible?

This study is looking for healthy volunteers who are at least 18 years old. Both men and women can take part. To be considered, you'll need to be in good general health.

The research staff will carefully check your health to make sure this study is safe for you. They will ask about your medical history and might do some tests. This is to ensure that participating in the study won't put your health at risk.

If you have certain health conditions or are taking particular medications, you might not be able to join. The medical team will explain all the requirements clearly to you.

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 at least 18 years old?
Are you generally in good health?
Are you able to attend several clinic visits?
Are you able to follow detailed study instructions?
Are you comfortable with having blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be a healthy volunteer. This means you won't have the condition that imatinib usually treats. You will be given both metamizole and imatinib during the study. The study looks at how your body handles these medicines, so you'll likely have several blood tests to measure the levels of the drugs in your system over time. You might also have other check-ups to monitor your overall health.

The study will involve several visits to a clinic over a period of time. You'll be given detailed instructions about when to take the medicines, what you can eat, and what activities to avoid. There will be careful monitoring by the study team throughout your participation. The total duration of your involvement in the study will be explained to you fully before you commit.

Potential risks and benefits

Potential benefits include contributing to important medical knowledge that can help make medicines safer and more effective for future patients. You might also receive a health check-up. However, there are potential risks, such as side effects from the medicines given, discomfort from blood tests, or unforeseen reactions. You will be closely monitored, and 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 'metamizole'?

Metamizole is a medicine sometimes used for pain relief and to reduce fever.

What is 'imatinib'?

Imatinib is a medicine used to treat certain types of cancer and other specific conditions.

Why is this study only for 'healthy volunteers'?

Early-stage studies often use healthy volunteers to understand how a drug works in a 'normal' body without other health conditions making it complicated.

Will I get paid for taking part?

The study team will tell you if there is any payment for your time and travel expenses before you agree to participate.

What does 'pharmacokinetics' mean?

Pharmacokinetics is how your body handles a medicine – how it absorbs it, distributes it, breaks it down, and gets rid of it.