Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Trial to Determine if Quabodepistat is Processed Differently in Adults with Reduced Liver Function Compared to Adults with Normal Liver Function

This research study is about a new medicine called quabodepistat, which is being developed to treat tuberculosis (TB). The main aim is to understand how this medicine is processed by the body when someone has a liver condition. Researchers will compare how the medicine acts in adults with reduced liver function against those with normal, healthy livers. This helps them work out the best and safest way to use the medicine for all patients, especially those who might have other health issues like liver problems. This is an early-stage study, meaning it's one of the first times this medicine is being tested in humans to see how it moves through the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Otsuka Pharmaceutical Development & Commercialization Inc.

Enrolment target

Start

19 Sep 2025

Tuberculosis

What is this study about?

This study is looking into a new medicine called quabodepistat, which is intended to treat tuberculosis (TB). TB is a serious infection, usually affecting the lungs, that can be treated with specific medicines. Before doctors can prescribe a new medicine widely, they need to understand exactly how it works in the body.

One very important thing to know is how the body breaks down and gets rid of medicines. Often, the liver plays a big part in this process. This study focuses on whether quabodepistat is handled differently in people who have some liver problems compared to those with healthy livers. This information is crucial because it helps doctors decide the right dose of medicine and ensure it's safe for people with different health conditions.

By understanding how the liver affects quabodepistat, researchers can make sure that when it's eventually used to treat TB, it can be given safely and effectively to everyone who needs it, even if they have other health issues. This is an early stage of human testing, helping to gather important safety and processing information before larger studies begin.

Key takeaways

This study is testing a new TB medicine called quabodepistat.
It aims to understand how the medicine is processed in the body.
Researchers are specifically looking at how liver health affects the medicine's behaviour.
It's an early-stage study (Phase I) focused on safety and how the body handles the drug.
Participation involves taking the medicine and having regular health checks and blood tests.

Who may be eligible?

This study is looking for adults aged 18 or over. It's open to both men and women. The main difference between the groups taking part will be their liver health.

Some participants will need to have a healthy liver, meaning it's working normally. Others will need to have some level of reduced liver function, meaning their liver isn't working as well as it should. Your doctor will be able to tell you if your liver falls into one of these categories.

Detailed medical checks will be done to make sure you fit the specific health requirements for the study. This helps keep everyone safe and makes sure the study results are accurate.

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 able to attend several appointments for health checks and blood tests?
Do you have a doctor who can provide your full medical history?
Are you prepared to potentially have either normal or reduced liver function, as determined by the study doctors?
Are you comfortable taking a new, experimental medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the new medicine, quabodepistat. You will need to attend several visits to the study clinic or hospital. During these visits, doctors and nurses will take blood samples to see how the medicine is processed in your body over time. They will also check your general health, blood pressure, and make sure you're feeling well.

The specific number of visits and tests will depend on which group you are in, but the overall aim is to carefully monitor your body's response to the medicine. You'll have regular check-ups to track any changes. The total duration of your participation will be explained in detail before you agree to join the study.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is helping researchers gain important knowledge about how this new TB medicine works, which could benefit future patients. It's important to remember that this is an early study primarily focused on understanding how the medicine is processed, not on treating your condition. Potential risks might include discomfort from blood tests and possible side effects from the medicine, though these would be carefully monitored. You will be given a full explanation of all known potential risks before you decide to participate. Remember, you can choose to leave 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.

—
Unverified
Bulgaria

Common questions

What is tuberculosis (TB)?

TB is a serious infection, usually in the lungs, caused by bacteria. It can be treated with special medicines.

What is quabodepistat?

Quabodepistat is a new medicine being developed to treat tuberculosis.

Why are researchers looking at liver function?

The liver plays a key role in breaking down and removing medicines from the body. Researchers want to see if quabodepistat is handled differently in people with liver problems to ensure it's safe for everyone.

Will I be given treatment for TB in this study?

This study is mainly about understanding how the medicine works in the body, not about treating your TB, if you have it. Your usual TB treatment would be separate, if applicable.

What is a Phase I study?

Phase I means it's an early-stage study, usually one of the first times a new medicine is tested in people. The main goal is to check safety and how the medicine moves through the body.