Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics Of Mavodelpar In Subjects With Impaired Hepatic Function

This study is investigating a new medicine called mavodelpar to understand how it is processed by the body in people with liver problems. We want to see how the body handles the medicine in those with mild, moderate, and severe liver issues, compared to people with healthy livers. This will help doctors learn the best and safest way to give mavodelpar to patients, ensuring they receive the correct dose. It's a key first step in developing the medicine and understanding its effects on different groups of people. The study will also carefully check for any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Reneo Pharmaceuticals Inc.

Enrolment target

Start

04 Jul 2023

Impaired Hepatic Function The study will enroll as following: · Group 1 (N =10) – Normal hepatic function (healthy subjects)single dose · Group 2 (N=8) – Mild hepatic impairment (Child-Pugh A - a score of 5 to 6)single dose · Group 3 (N=8) – Moderate hepatic impairment (Child-Pugh B a score of 7 to 9)single dose · Group 4 (N=6) – Severe hepatic impairment (Child-Pugh C a score of 10 to 15)single dose Healthy volunteers with normal hepatic function.

What is this study about?

This study is a bit like a detective story, but for medicine. We're trying to understand how a new drug, mavodelpar, moves through and is processed by the body. This is especially important when someone has liver problems, as the liver plays a big role in breaking down medicines. Think of the liver as the body's processing plant; if it's not working perfectly, it might handle medicines differently.

The main goal is to compare how mavodelpar acts in people with healthy livers versus those with mild, moderate, or severe liver problems. We'll be looking at things like how much of the drug gets into the bloodstream and how long it stays there. This information is crucial for doctors to figure out the right dose for each patient, making sure it's both effective and safe.

This study is an early step, called a 'Phase 1' study, which focuses on understanding how the drug works in the body and checking for any early safety concerns. It's not about treating a specific illness, but about gathering vital information about the medicine itself. We'll be carefully monitoring participants for any side effects and checking their overall health.

Key takeaways

This study is testing a new medicine called mavodelpar.
It aims to understand how the medicine is processed by the body in people with healthy livers and those with liver problems.
This information helps doctors decide the safest dose for future patients.
It's an early-stage study focused on safety and how the drug works.
Your health would be carefully monitored throughout your participation.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women can take part.

We are looking for different types of people to participate. Some participants will have healthy livers, while others will have varying degrees of liver impairment – meaning your liver isn't working as well as it should. This includes people with mild, moderate, and severe liver problems. Your doctor will be able to tell you if your liver condition fits into one of these groups.

It's important that we can get a clear picture of how mavodelpar works in different people, so there will be specific health requirements that your doctor will check to make sure the study is right for you.

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 appointments at the study clinic?
Do you have a healthy liver, or a mild, moderate, or severe liver problem?
Are you willing to take a single dose of the study medicine?
Are you able to provide blood and urine samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single dose of the study medicine, mavodelpar. Throughout the study, our medical team would regularly check your health. This would involve typical medical assessments such as blood tests (to look at your liver, kidney, blood count, etc.), urine tests, and monitoring your vital signs, like blood pressure, pulse, and temperature. We'll also take measurements of your heart activity using an electrocardiogram (ECG) to ensure your heart is healthy. The total duration of your participation, including follow-up, would be discussed in detail by the study team.

Potential risks and benefits

Taking part in a study like this helps us learn more about new medicines, which could ultimately help other patients in the future. However, there are potential risks, as with any medicine. Mavodelpar is new, and while we will monitor you very closely, there's always a chance of side effects, some of which might not be known yet. You will be told about all known risks before you decide to join, 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 function'?

It means how well your liver is working. Your liver is really important for cleaning your blood and processing medicines.

What is mavodelpar?

It is a new medicine being studied. In this particular trial, we are trying to understand how it acts in the body.

Will I get better if I join this study?

This study is not designed to treat an illness. Its main purpose is to gather information about the new medicine, not to improve your health condition directly.

How long will I be in the study?

You will receive a single dose of the medicine. The total time you spend in the study, including follow-up checks, will be explained by the study team.

Do I have to take part?

No, it is completely your choice. You can say no, or withdraw at any time, and it won't affect your normal medical care.