Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study About Fazirsiran in People With and Without Liver Problems.

This study is investigating a new medicine called fazirsiran. We are particularly interested in understanding how this medicine behaves in the body of adults, both in those who have existing liver problems and in those who have healthy livers. This is a very early stage of research, often called Phase 1, which means we are mainly trying to learn how the medicine is absorbed, how it works, and how the body gets rid of it. We also want to check if it's safe. There isn't much known about it yet, but this research is an important step to see if fazirsiran could be a useful treatment in the future. The study is open to all adults aged 18 and over.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Takeda Development Center Americas Inc.

Enrolment target

Start

04 Sep 2023

Hepatic impairment.

What is this study about?

Imagine the doctors are trying out a brand new key for a lock, but they don't know much about how that key will work in different types of locks. This study is a bit like that. Our new 'key' is a medicine called fazirsiran. The main aim of this study is to learn more about how this medicine behaves in the human body.

We specifically want to see if having liver problems changes how the body handles fazirsiran. Will it be absorbed differently? Will it stay in the body longer? These are important questions because the liver plays a big role in breaking down medicines. By understanding this, doctors can figure out the right amount of medicine to give to people, especially those with liver conditions.

Because this is an early study (often called Phase 1), it means we are focusing on safety and how the medicine moves through the body, rather than whether it can cure a specific illness. It's a crucial step in developing new medicines, helping us decide if it's safe enough and promising enough to continue with further research.

Key takeaways

This study is testing a new medicine called fazirsiran.
It's an early-stage study to understand how the medicine works and if it's safe.
Researchers are particularly interested in how liver health affects the medicine.
Participation involves clinic visits, tests, and being given the study medicine.
You won't necessarily get direct health benefits, but your involvement helps future research.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

One of the main things we're looking for is whether you have liver problems or not. Some people in the study will have healthy livers, and others will have different degrees of liver impairment.

Because this is a general study to understand how a new medicine works in the body, there isn't a specific illness you need to have to take part, other than the varying states of liver health for some participants.

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 study appointments regularly?
Are you willing to have blood tests and other health checks?
Are you comfortable taking a new, unapproved medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several visits to a clinic. During these visits, doctors and nurses will carry out checks, such as blood tests, to see how the medicine is affecting you. You will be given the study medicine, fazirsiran, and will be carefully monitored afterwards.

The number of visits and the total time you spend in the study will depend on the specific part of the study you are in. It will involve regular check-ups to make sure you are well and to collect information about the medicine. You will be told the exact schedule before you agree to take part. It's important to know that you can choose to leave the study at any time.

Potential risks and benefits

Taking part in a study like this means you might not directly benefit from the medicine, as it's very early research. However, your participation will help doctors learn more about fazirsiran, which could help future patients. There are always potential risks with new medicines, such as side effects, though we don't know what they are yet. The study team will explain all known and potential risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Hungary
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Unverified
Slovakia

Common questions

What is fazirsiran?

Fazirsiran is a new medicine that is being studied. We are trying to understand how it works in the body.

Why are you studying people with and without liver problems?

The liver plays a big part in how our bodies process medicines. We want to see if having liver problems changes how fazirsiran works.

Will taking part help me feel better?

This is an early study, so it's not designed to treat an illness, and you might not feel better. Your participation will help future medical research.

How long will I be in the study?

The exact length of time will be explained by the study team, but it varies depending on the specific part of the study you join.

Can I stop taking part if I change my mind?

Yes, absolutely. You can choose to leave the study at any time, and it won't affect any of your other medical care.