Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to investigate the mass balance, absolute bioavailability (BA), pharmacokinetics (PK), and metabolism of a single oral dose 60 mg [14C]-alogabat and an IV microdose of 100 μg [13C]-alogabat

This research study is designed for healthy adult men to understand how a new medicine, called alogabat, works inside the body. We're interested in something called 'mass balance,' which means tracing where the medicine goes and how it leaves the body. We'll also look at 'bioavailability,' which tells us how much of the medicine actually gets into your bloodstream when you take it by mouth. The study will also explore 'pharmacokinetics,' which is about how quickly the medicine is absorbed, how long it stays in the body, and how it's broken down. Finally, we'll learn about its 'metabolism' – how your body changes the medicine. This initial study helps scientists understand the fundamental properties of alogabat.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

26 Oct 2023

There is no medical condition being investigated.Not applicable (NA)

What is this study about?

This study is a very early-stage research project. It's not looking to treat any illness, but rather to understand how a new investigational medicine, called alogabat, behaves in the human body. Think of it like learning how a car works: you need to understand how the engine uses fuel, how quickly it moves, and how it gets rid of exhaust, even if you're not trying to fix a broken car.

Specifically, researchers want to see where the medicine goes in the body, how much of it reaches the bloodstream when taken by mouth (its 'bioavailability'), and how the body processes it. This involves understanding how quickly the medicine gets into your system, how long it stays there, and how your body breaks it down and gets rid of it. This information is crucial for scientists to learn about the basic properties of alogabat.

Gathering this information in healthy people is a vital first step in developing any new medicine. It helps scientists decide if the medicine is worth further investigation and how it might be given to patients in future studies. It's all about building a foundational understanding before it can ever be considered for treating specific health conditions.

Key takeaways

Early-stage study for a new medicine called alogabat.
Aims to understand how the medicine works in healthy men.
Not for treating any specific illness.
Involves a single dose of medicine, taken by mouth and intravenously.
Close monitoring, including blood and urine tests.
Participation helps future medicine development.

Who may be eligible?

This study is specifically designed for healthy adult men. To be considered, you must be 18 years old or older, with no upper age limit currently mentioned.

Because this is a very early study looking at how a medicine works in the body, participants need to be in good overall health. This ensures that any effects seen are due to the medicine itself and not due to existing health conditions. A medical team will check your health carefully.

Since no medical condition is being investigated, it means that even if you have a health issue, this study is not looking to treat it. The focus is purely on understanding the medicine's behavior in a healthy system.

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.

Am I a male?
Am I 18 years old or older?
Am I generally healthy?
Am I willing to stay at a clinic for monitoring if required?
Are all my current medications approved by the study team?

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, alogabat. This would involve taking a small amount of the medicine by mouth, which has a special tag on it (called [14C]-alogabat) to help scientists track it in your body. You would also receive a very tiny amount of the medicine directly into your bloodstream, through a drip (an IV microdose of [13C]-alogabat).

Throughout the study, the research team would closely monitor you. This would likely involve staying at a clinic for a period of time. They would take regular samples of your blood and possibly other body fluids (like urine) to see how the medicine is absorbed, where it goes, and how your body breaks it down and gets rid of it. The total duration of your participation, including all visits and follow-ups, would be explained to you in detail by the study team.

Potential risks and benefits

As with any research study involving a new medicine, there could be potential risks, including side effects from the single dose of alogabat or the procedures involved, like blood tests. The medical team will monitor you closely for any reactions. The potential benefit for you personally is primarily contributing to medical knowledge that could help develop future treatments, rather than direct health improvement, as this study is not for a specific condition. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your future 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
Netherlands

Common questions

What is alogabat?

Alogabat is a new medicine that is being studied for the first time in people. This study is not looking to use it as a treatment yet, but rather to understand how it works in the body.

Will this study help me with a specific health problem?

No, this study is not designed to treat any medical condition. It's focused purely on understanding how the new medicine behaves in healthy people.

Why use 'tagged' medicine?

The medicine has special tags (like tiny trackers) that help scientists follow its journey through your body. This allows them to see exactly where it goes and how your body processes it.

How long will I need to be involved?

The exact duration will be explained by the study team, but it will involve receiving a single dose of the medicine and then being monitored closely for a period of time afterward.

Do I have to take part if I'm asked?

No, taking part in any study is completely voluntary. You can decide not to participate or withdraw at any time without any consequences for your usual medical care.