Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Safety, tolerability, pharmacokinetics and pharmacodynamics of ARV-102 in healthy participants

This research is looking at a new medicine called ARV-102. It's designed to help people with Parkinson's disease, but for this first study, we are inviting healthy male volunteers to take part. The main aim is to understand if ARV-102 is safe when given to humans for the very first time. Researchers will also be checking how the body takes in, uses, and gets rid of the medicine. They'll also be looking for any signs of how the medicine works in the body. This type of early study is important to make sure a medicine is safe enough to test in people who actually have the condition it's designed to treat.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Arvinas Operations Inc.

Enrolment target

Start

21 Dec 2023

Parkinson's Disease

What is this study about?

Imagine scientists have created a new key that they hope will unlock a solution for Parkinson's disease. Before they can try this key in locks with Parkinson's, they first need to check if the key itself is safe to handle and how it works. That's exactly what this study is about for a new medicine called ARV-102.

This study is the very first time ARV-102 will be given to people. It's a really early step in developing new medicines. We're not testing if it helps Parkinson's disease yet. Instead, we're focusing on healthy volunteers to see if the medicine is safe, if it causes any unwanted side effects, and how your body processes it – for example, how much stays in your system and for how long. We'll also look for any early clues about how the medicine might affect the body.

The insights we gain from this study are incredibly important. They help researchers understand if ARV-102 is safe enough to continue testing in people who have Parkinson's disease. It's a foundational step that helps ensure new treatments are developed responsibly and safely for future patients.

Key takeaways

This is a first-in-human study of a new medicine for Parkinson's disease.
It aims to check the safety and how the body handles the medicine (ARV-102) in healthy people.
Only healthy adult men, aged 18 and over, can take part.
You won't get direct health benefits, but you'll help medical research.
Participation involves clinic visits and close monitoring.
You can stop participating at any time.

Who may be eligible?

This study is looking for a very specific group of people to take part. To be eligible, you must be an adult male, aged 18 years or older. There is no upper age limit for this study, so older men are also welcome to inquire.

It's important to know that this study is only open to healthy individuals. This means you should not have any significant ongoing medical conditions, especially Parkinson's disease, as the main goal is to test the medicine's safety in people who are well.

Before you can join, the study team will carefully check your health to make sure you fit all the requirements. This will likely involve a medical examination and some tests.

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 a male?
Are you 18 years old or older?
Do you consider yourself generally healthy?
Do you NOT have Parkinson's disease?
Are you able to attend study visits as required?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new study medicine, ARV-102. This being the first time humans are receiving the drug, you would be closely monitored by doctors and nurses. This would involve a number of visits to the study clinic, and it's possible you might need to stay overnight or for several days for the initial doses so the team can monitor you very carefully.

During your time in the study, you would have regular health checks, including blood tests, urine tests, and possibly heart checks (like an ECG). These are to make sure you are staying well and to see how your body is handling the medicine. You would also be asked questions about how you are feeling and any effects you experience. 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

Taking part in any medical study has potential benefits and risks. For you, as a healthy volunteer, the main benefit is contributing to medical science and helping to develop potential new treatments for Parkinson's disease. There's no direct personal health benefit expected for you. Potential risks might include side effects from the study medicine, which could be mild (like a headache or feeling tired) or, rarely, more serious. There's also the time commitment and discomfort from blood tests or other procedures. You will be fully informed of all known risks before you decide to join, and you are free 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.

—
Unverified
Netherlands

Common questions

What is ARV-102?

ARV-102 is a new medicine being developed to potentially treat Parkinson's disease.

Why are healthy people needed for a Parkinson's disease study?

This early study checks if the medicine is safe and how it acts in the body of healthy people before testing it in patients with Parkinson's disease.

Will I have Parkinson's disease if I join this study?

No, this study is only for healthy individuals. You must not have Parkinson's disease to participate.

Will I get paid for taking part?

Payment to cover your time and travel for participating in such studies is often offered, but you should ask the study team for details.

What is a Phase 1 study?

A Phase 1 study is the very first time a new medicine is given to humans, mainly to check its safety and how the body handles it.