Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Pharmacokinetic study of minocycline in patients with nontuberculous mycobacterial disease

This study is looking into a medicine called minocycline. We want to understand how it works in the body of people who have a condition caused by germs called nontuberculous mycobacteria. These germs are different from the ones that cause tuberculosis. This is a very early study, called a 'Phase I' study, which means we are mainly checking how the medicine is absorbed, how it spreads around the body, and how it is removed. It's a bit like checking the medicine's journey to make sure it's doing what we expect. There isn't a lot of information about this condition, so we are trying to learn more to help people in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Radboud universitair medisch centrum Stichting

Enrolment target

Start

24 Sep 2024

Nontuberculous mycobacterial disease

What is this study about?

This study is about a medicine called minocycline. We want to understand exactly what happens to this medicine inside the bodies of people who have a specific type of infection. This infection is caused by germs called 'nontuberculous mycobacteria' – you can think of them as tiny bugs. They are related to the germ that causes tuberculosis, but they are not the same.

Doctors and researchers are doing this study because they need to learn more about how minocycline acts when someone has this infection. They want to check things like how much of the medicine gets into the blood, how long it stays there, and how the body gets rid of it. This helps them work out the best and safest ways to use the medicine in the future.

This is a 'Phase I' study, which means it's one of the first steps in testing a new use for a medicine. It’s focused on understanding the medicine itself rather than whether it can cure the disease right away. By taking part, you could help doctors learn important information that might lead to better treatments for nontuberculous mycobacterial disease in the future.

Key takeaways

This study is looking at how a medicine called minocycline works in people with 'nontuberculous mycobacterial disease'.
It's an early-stage study to understand how the medicine moves through the body.
Adults aged 18 and over, both men and women, with the specific infection can take part.
Participation involves clinic visits, likely blood tests, and receiving the study medicine.
The main goal is to gather information to help future patients, not to treat participants directly.
You can stop participating in the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. There is no upper age limit, meaning people of any age above 18 can take part.

Both men and women can join this study. The researchers are looking for people who have been diagnosed with an infection caused by 'nontuberculous mycobacteria'.

There might be other health checks you need to pass to make sure the study is a safe option for you. It's important to talk to your doctor or the study team to find out if this study is a good fit for your specific health situation.

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?
Have you been diagnosed with 'nontuberculous mycobacterial disease'?
Are you a man or a woman?
Are you able to attend clinic visits as required?
Are you willing to take the study medicine and have blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, minocycline. The study will involve several visits to a clinic over a short period. During these visits, doctors and nurses will usually take blood samples to measure how much of the medicine is in your body at different times. They might also do other health checks, like measuring your heart rate or blood pressure, to make sure you are doing well.

The overall length of time you'd be involved in the study isn't specified, but these types of studies usually involve a few visits over a few days or weeks rather than months or years. You would be given clear instructions on when and where to go, and what you need to do. All your questions would be answered before you start.

Potential risks and benefits

Taking part in any study has possible benefits and risks. A potential benefit of this study is helping doctors learn more about how minocycline works, which could lead to better treatments for nontuberculous mycobacterial disease in the future. As an early-stage study, it's not designed to directly treat your condition, so there might not be a direct personal health benefit to you. Potential risks could include side effects from the study medicine, like an upset tummy, skin reactions, or feeling dizzy. There's also the discomfort of blood tests. The study team will explain all known risks to you. Remember, you can choose to leave 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
Netherlands

Common questions

What is 'nontuberculous mycobacterial disease'?

It's an infection caused by tiny germs, similar to those that cause tuberculosis, but they are different. They can cause problems in the lungs or other parts of the body.

What is minocycline?

Minocycline is a type of antibiotic medication often used to treat various bacterial infections. This study is looking at how it works for your specific condition.

Is this a new medicine?

No, minocycline has been around for some time. This study is looking at how it behaves in the body of people with a particular infection, rather than testing a brand new drug.

Will I get better if I join this study?

This study is mainly to learn more about the medicine itself, not to say if it will directly treat your condition. It might help doctors find better treatments for others in the future.

How long will I need to be in the study?

The exact duration isn't given, but these types of studies usually involve a few clinic visits over a short period, like days or weeks, for observation and blood tests.