Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study investigating the safety, absorption, and elimination of radioactively labeled RO7269162, a new compound that may potentially be used in the treatment of Alzheimer’s disease.

This study is about a new medicine called RO7269162, which could potentially help people with Alzheimer's disease. Before we can test it in people with Alzheimer's, we first need to make sure it's safe and understand how it works in the body. This study will involve healthy men and will look at how the body absorbs this new medicine, how it travels through the body, and how the body gets rid of it. To do this, we'll use a very small, harmless amount of a special marker, called a radioactive label, attached to the medicine. This is a very early stage of testing, known as a Phase 1 study, and it's a crucial step to see if this medicine might be helpful in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

10 Oct 2024

Healthy males volunteers

What is this study about?

Imagine scientists are trying to build a new car. Before they can let people drive it on the roads, they need to do lots of tests in a safe environment. This study is a bit like that, but for a new medicine called RO7269162, which we hope might one day help people with Alzheimer's disease.

Alzheimer's disease affects memory, thinking, and behaviour. Finding new treatments is really important. This particular study is the very first step in testing this new medicine in humans. We're not yet testing if it can treat Alzheimer's; instead, we're focusing on understanding its basic properties.

Specifically, we want to know what happens to this medicine once it's inside the body. We'll be looking at how well the body takes it in, where it goes, and how quickly the body gets rid of it. This information is vital for future studies, as it helps us decide if the medicine is safe enough to test in people who actually have Alzheimer's, and what the right dose might be.

Key takeaways

This study is testing a new medicine for Alzheimer's called RO7269162.
It's a very early safety study, conducted in healthy male volunteers.
Researchers want to understand how the medicine moves through and leaves the body.
A small, safe marker helps track the medicine inside the body.
This study helps pave the way for future research into Alzheimer's treatments.
Participation involves clinic visits and careful monitoring.

Who may be eligible?

This study is looking for healthy male volunteers.

You would need to be 18 years old or older to take part. There is no upper age limit mentioned, but you would still need to be considered generally healthy by the study doctors.

This study is not open to women, or to men who have serious health problems. It's important that participants are healthy so we can clearly see how the new medicine behaves without other health conditions complicating the results.

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 male?
Are you 18 years old or older?
Do you consider yourself generally healthy?
Are you able to attend several clinic visits for tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new medicine, RO7269162, which will contain a very small, safe amount of a special marker. This marker helps the researchers track the medicine in your body. You would need to attend several visits to the study clinic over a period of time. During these visits, the study team would perform various assessments, such as taking blood samples, urine samples, and possibly scans to see where the marked medicine goes and how your body removes it. You would be closely monitored for any effects of the medicine. The total duration of your participation would be explained in full at the start, including all follow-up appointments.

Potential risks and benefits

Taking part in this study may not directly benefit your health, as it's an early-stage test in healthy individuals. However, you would be helping medical science learn more about a potential new treatment for Alzheimer's disease, which could help many people in the future. As with any medicine, there is a possibility of side effects, which the study team will explain in detail. All procedures carry some level of risk, and you will be carefully monitored throughout. 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
Netherlands

Common questions

What is Alzheimer's disease?

Alzheimer's disease is a condition that affects the brain, causing problems with memory, thinking, and behaviour, and it gradually gets worse over time.

What does 'radioactively labeled' mean?

It means a tiny, harmless amount of a special marker has been attached to the medicine. This marker allows researchers to track where the medicine goes in your body using special equipment, like a GPS for the medicine.

Will this medicine treat my health problems?

No, this study is not designed to treat any health problems. It's about understanding how a new medicine works in healthy people before it can be tested as a treatment.

Why is this study only for men?

Sometimes, in early-stage studies, researchers limit participants to one sex to simplify the initial findings and understand the medicine's basic behaviour without potential differences between sexes confusing the results. This is common in very early drug development.

What is a 'Phase 1' study?

Phase 1 is the very first stage of human testing for a new medicine. It focuses on how safe the medicine is, how the body handles it (absorbs, distributes, metabolises, and excretes it), and finding a safe dose range, usually in healthy volunteers.