Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1, Open-label, Pharmacokinetic Study of TVB-2640 in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Function.

This research study aims to understand how a new investigational medicine, TVB-2640, works in the body and how it is processed. Specifically, it compares how the drug is handled by people who have perfectly healthy livers to those who have different levels of liver damage – mild, moderate, or severe. This type of study is important in the early stages of drug development to learn how effective doses might need to be adjusted for people with liver conditions. It’s an open-label study, meaning both the researchers and the participants will know which treatment is being given.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Sagimet Biosciences Inc.

Enrolment target

Start

24 Aug 2023

What is this study about?

This study is about a new medicine called TVB-2640. When doctors develop new medicines, they need to understand how the body uses and gets rid of them. This is especially important for organs like the liver, which plays a big role in breaking down medicines. This study will carefully watch how TVB-2640 moves through the body in different groups of people.

We'll be looking at people with healthy livers and comparing them to those who have mild, moderate, or severe liver problems. This research will help us understand if liver health affects how much of the medicine stays in the body and for how long. This knowledge is crucial for future studies to ensure the medicine is given safely and effectively to everyone who might need it, including those with liver conditions.

The main goal is to find out if the dose of TVB-2640 might need to be different for people with various levels of liver impairment. By doing this, we can make sure that if the medicine goes on to be used more widely, it will be safe and work well for as many people as possible.

Key takeaways

This study investigates a new medicine, TVB-2640.
It compares how the medicine works in people with healthy livers versus those with liver problems.
The levels of liver problems being studied are mild, moderate, and severe.
The aim is to understand how liver health affects the medicine's processing.
Participation will involve medical checks and monitoring.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old, and there's no upper age limit. Both men and women can take part.

Participants will be divided into different groups. One group will be made up of people with healthy livers. The other groups will include people who have been diagnosed with mild, moderate, or severe liver problems.

Doctors will confirm your liver health using a specific scoring system. This ensures that everyone is placed in the correct group and that 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 a man or a woman?
Do you have a healthy liver, or have you been told you have mild, moderate, or severe liver impairment?
Are you able to attend all required study appointments?

Answer every question to see your result.

What does participation involve?

This study is still in the early stages, focusing on understanding how the drug works. While the detailed steps aren't provided, typically in this kind of study, you would likely: attend screening appointments to confirm you're suitable; receive the study medication (TVB-2640); have regular blood tests to check how the medicine is processed by your body; and attend follow-up visits. The total duration of your involvement, including all visits and checks, would be fully explained before you decide to take part.

Potential risks and benefits

Taking part in early-stage trials like this comes with potential benefits and risks. A potential benefit is contributing to medical science and helping to understand how new medicines work, which could eventually lead to new treatments. However, there are potential risks, such as experiencing side effects from the investigational medicine, or discomfort from procedures like blood tests. You will be closely monitored by a medical team. It's very important to remember that participating is entirely your choice, and you 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.

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Unverified
Hungary

Common questions

What is 'hepatic impairment'?

It's a medical term for liver damage or when your liver isn't working as well as it should.

What does 'open-label' mean?

It means that both you and the study doctors will know that you are receiving the study medicine, TVB-2640.

What are 'Child-Pugh A, B, and C'?

These are ways doctors score how well your liver is working. 'A' is mild impairment, 'B' is moderate, and 'C' is severe.

Why is this study important?

It helps researchers understand how a new medicine is processed in people with different levels of liver health, which is vital for safe and effective dosing in the future.

Will I get better if I join this study?

This study is not primarily designed to treat your condition but to understand how a new medicine works in the body. Any potential health changes would be a secondary outcome.