Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to assess the safety, tolerability and pharmacokinetics of tideglusib in subjects with hepatic impairment compared to healthy subjects.

This research is testing a new medicine called tideglusib. The main goal is to understand how safe the medicine is and how the body uses and gets rid of it. We are particularly interested in seeing if there are differences in people who have liver problems compared to those with healthy livers. This kind of early study helps doctors learn important information about new medicines. It's a first step to make sure future treatments are as safe and effective as possible for everyone. By comparing these two groups, researchers can figure out the right way to use tideglusib, especially for patients with different health conditions.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Amo Pharma Limited

Enrolment target

Start

09 Oct 2024

Hepatic impairment Healthy subjects

What is this study about?

Imagine a new medicine that could help people. Before it can be used widely, doctors need to understand it really well. This study is doing just that for a medicine called tideglusib. The main aim is to see how safe it is when people take it, and how their bodies process it.

Think of your liver like a filter for your body. It helps break down medicines and get rid of them. If someone has liver problems, their body might handle medicines differently. This study wants to find out if tideglusib behaves differently in people with liver issues compared to those with healthy livers. This is super important because it helps scientists work out the right dose and makes sure the medicine is safe for everyone, no matter their liver health.

This is an early stage of research, often called human pharmacology. It means we're learning the basic ways the medicine works in people. It's a crucial step in developing new treatments and ensuring they are given safely and effectively to patients who might need them in the future.

Key takeaways

This study is testing a new medicine called tideglusib.
It aims to understand how safe the medicine is and how the body handles it.
Researchers are comparing people with liver problems to healthy volunteers.
It's an early-stage study, helping scientists learn basic information.
Participation helps future patients get safer, more effective medicines.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study welcomes both men and women.

There are two main groups of people this study is looking for: those who have some level of liver problems (hepatic impairment) and those who are generally healthy. The researchers will look at specific details of your health to decide which group you might fit into, or if the study is right for you.

It's important to remember that even if you meet these general age and sex requirements, there might be other health conditions or medicines you're taking that could mean you can't join. A doctor on the study team would check all of these details with you.

Quick self-check

Are you 18 years old or older?
Are you a man or a woman?
Do you have a healthy liver, or do you have known liver problems?
Are you able to attend appointments as required by the study team?

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

What does participation involve?

The detailed plan for what taking part involves isn't provided here, but typically, these kinds of studies involve several visits to a clinic. You might be given the study medicine, tideglusib, and then doctors and nurses would carefully check your health. This could include blood tests, urine tests, and monitoring your vital signs like blood pressure and heart rate to see how your body reacts to the medicine.

There would likely be specific days for taking the medicine and follow-up visits to track its effects and how quickly it leaves your system. The total duration of your participation would depend on the study design, but generally, early-stage studies can last from a few weeks to a few months, with follow-up appointments after you stop taking the medicine to ensure you are well.

Potential risks and benefits

Participating in a study means you're helping science, which is a great benefit to others. While there's no guarantee the medicine will directly benefit you, it might offer early access to a new treatment. However, all medicines have potential risks, like side effects, and some might be unknown with a new drug. The study team will explain all known risks. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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Bulgaria

Common questions

What is 'hepatic impairment'?

Hepatic impairment simply means having problems with your liver, which can affect how your body handles medicines.

What does 'pharmacokinetics' mean?

It's a scientific term that means how your body takes in, uses, and gets rid of a medicine. Basically, what the body does to the drug.

Why are healthy people included in the study?

Healthy people are included so researchers can compare how the medicine works in someone with a healthy liver versus someone with liver problems.

Is tideglusib a new medicine?

Yes, this is an early-stage study, meaning tideglusib is a new or experimental medicine that is still being researched.

Will I get paid for taking part?

Often, early-stage studies offer payment for your time and travel, but you would need to ask the study team for details.