Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Assessment of the influence of the gut microbiome on tacrolimus pharmacokinetics in healthy volunteers

This research study is about understanding how the 'gut microbiome' – the trillions of tiny bacteria and other organisms living in our intestines – affects a common medicine called tacrolimus. Tacrolimus is a powerful drug often used to stop the body from rejecting a new organ after a transplant. In this study, healthy volunteers will take tacrolimus, and researchers will carefully measure how their bodies process the drug. This is a very early-stage study, sometimes called a Phase 1 study, and its main goal is to learn how the drug moves through and is cleared from the body. It doesn't test if the drug treats illnesses, but rather aims to understand its basic effects. This knowledge could help doctors better manage this important medicine in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Universitaetsklinikum Heidelberg AöR

Enrolment target

Start

31 Jul 2023

Pharmacokinetic trial in healthy volunteers

What is this study about?

This study is called a 'pharmacokinetic' study, which is a scientific way of saying it's about how your body handles a medicine. Think of it like this: when you take a pill, your body absorbs it, moves it around, changes it, and then gets rid of it. This study specifically wants to see how your gut microbiome – that's all the tiny bacteria and other bugs living in your intestines – might affect this whole process for a drug called tacrolimus.

Tacrolimus is a very important medicine, usually given to people who have had an organ transplant, like a new kidney or liver. It helps stop their immune system from attacking and rejecting the new organ. However, it can be tricky to get the dose just right, because everyone's body handles it a bit differently. We know that the bugs in our gut can play a role in how we digest food and even how our bodies use some medicines. This study wants to find out if these gut bugs affect tacrolimus specifically.

By carefully studying healthy volunteers, researchers hope to learn more about the link between our gut microbiome and how tacrolimus works in the body. This information won't directly change how the drug is used today, but it's a vital step to understanding it better. In the long run, this kind of research could help doctors prescribe tacrolimus more effectively and make it safer for people who rely on it after an organ transplant.

Key takeaways

This study explores how gut bacteria affect a medicine called tacrolimus.
It involves healthy volunteers to understand basic drug processing.
Tacrolimus is commonly used in organ transplant patients.
The research aims to improve future understanding and use of the drug.
Participation involves clinic visits, taking medicine, and blood tests.

Who may be eligible?

To join this study, you need to be a healthy adult, aged 18 or older. Both men and women are welcome to take part. Because this study is aimed at understanding how a medicine works in healthy people, you shouldn't have any major ongoing health problems.

Researchers will need to check your medical history and do some health assessments to make sure you are suitable and that it would be safe for you to participate. This is to protect your well-being throughout the study.

It’s important to remember that this study is not for people who are currently using tacrolimus, or who have had an organ transplant. It’s specifically for healthy volunteers who can help us understand the basic effects of the drug.

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?
Are you generally healthy and don't have any major ongoing health conditions?
Are you able to attend several clinic visits as required?
Are you willing for researchers to take blood samples and potentially other samples (like stool)?
Are you able to understand and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to attend several visits to a clinic or research unit. During these visits, you would be given a dose of the study medicine, tacrolimus. Researchers would then take regular blood samples to measure how the medicine is absorbed, moves through your body, and is eventually cleared out.

You might also be asked to provide other samples, like stool (poo) samples, so the researchers can look at your gut microbiome. There will be careful monitoring of your health throughout the study to make sure you are safe and well. The total duration of your involvement, including all visits and follow-up, would be fully explained to you before you agree to join.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of this study is contributing to important medical knowledge that could eventually help people who rely on tacrolimus. However, there is no direct personal medical benefit for participants. Potential risks could include side effects from the study medication, discomfort from blood tests, or inconvenience from the time spent at the clinic. All possible side effects and risks will be fully explained before you agree to participate. You 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 is tacrolimus?

Tacrolimus is a medicine often used to prevent the body from rejecting a new organ after a transplant, like a kidney or liver.

What is the gut microbiome?

It's the name for the trillions of tiny bacteria and other organisms that live in your intestines, playing a role in your health and how you process things.

Will I get better if I join this study?

No, this study is for healthy volunteers and is designed to understand how a drug works, not to treat an illness in participants.

Will I have to stay in the hospital?

The study involves several clinic visits for tests and to take the medicine, but whether it includes overnight stays would be fully explained by the research team.

Is this a new medicine?

No, tacrolimus is an existing medicine. This study is about understanding how healthy bodies respond to it, especially considering the gut microbiome.