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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1, Multi-Cohort, Open-Label, Randomized Pilot Study to Evaluate the Effect of Food and a Proton-Pump Inhibitor (esomeprazole) on the Single-Dose Pharmacokinetics of ARV-102 in Healthy Participants.

This study is a Phase 1 clinical trial designed to understand how a new medicine, ARV-102, works in the body. It's specifically looking at people with Parkinsonian syndromes. Researchers want to find out how ARV-102 is absorbed and processed when taken with food, and also when taken alongside a common stomach acid-reducing medicine called esomeprazole. This is a very early stage of testing, and it involves healthy volunteers rather than patients with the condition. The main goal is to understand how the body handles this new medicine under different conditions before it is given to patients.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Arvinas Operations Inc.
Enrolment target
24
Start
14 Nov 2025

What is this study about?

Imagine you have a new key, but you're not sure if it works best when your hands are empty or when you're holding a sandwich. This study is a bit like that, but for a new medicine called ARV-102. Researchers are trying to understand how this medicine behaves in the body, especially when someone has recently eaten food or when they are also taking another common medicine called esomeprazole, which helps with stomach acid.

This is a very early stage of research, called a Phase 1 study. The main goal of these early studies is to see if a new medicine is safe and how it moves through the body, rather than whether it treats a specific illness. Because of this, the study is being done in healthy volunteers, meaning people who don't have Parkinsonian syndromes.

The information gathered from this study will be really important. It will help doctors and scientists understand the best way to give ARV-102 in the future, if it proves helpful for people with Parkinsonian syndromes. Learning how food and other medicines affect ARV-102 will help make sure patients eventually get the right dose at the right time.

Key takeaways

  • This is an early study of a new medicine, ARV-102, for Parkinsonian syndromes.
  • It tests how food and stomach acid medicine affect ARV-102 in healthy adults.
  • The goal is to understand how the medicine works in the body.
  • Participants take a single dose of ARV-102 under different conditions.
  • Results will help guide future studies and potential treatment use.
  • It's a Phase 1 study, focusing on safety and how the body handles the medicine.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. Both men and women can take part.

Because this is an early study to check how the medicine works in the body, it's not looking for people who currently have Parkinsonian syndromes or other serious health problems. The study needs participants who are generally well so that researchers can clearly see how the new medicine behaves on its own.

There might be other specific health checks or conditions that mean you can't join, which the study team will explain in detail if you are interested.

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.

  1. Are you 18 years old or older?
  2. Are you generally healthy?
  3. Are you a man or a woman?
  4. Are you not currently pregnant or breastfeeding (if applicable)?
  5. 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 a single dose of the study medicine, ARV-102. On some occasions, you might receive it after eating, or after taking a common stomach acid medicine called esomeprazole. The study team will take blood samples regularly to see how your body processes the medicine. You will also have check-ups to monitor your general health and how you feel after taking the medicine. The total duration of your involvement, including all visits and follow-up, will be explained fully by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. The main benefit is helping advance medical knowledge, which could lead to better treatments for conditions like Parkinsonian syndromes in the future. As this is an early-stage study, you may not directly benefit from the medicine. Potential risks could include side effects from the study medicine or discomfort from blood tests. You will be closely monitored, 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.
  • Unverified
    Netherlands

Common questions

What are 'Parkinsonian syndromes'?

Parkinsonian syndromes are conditions that cause symptoms similar to Parkinson's disease, like tremors, stiffness, and problems with movement.

Why is this study looking at healthy people?

Early studies like this often use healthy volunteers first to safely understand how a new medicine works in the body, including how it's absorbed and processed, before it's given to patients who are unwell.

What is esomeprazole?

Esomeprazole is a common medicine used to reduce stomach acid, often prescribed for heartburn or acid reflux.

Will I get the new medicine only once?

Yes, in this specific study, participants will receive a single dose of the medicine at a time, sometimes with food or with esomeprazole.

What does 'single-dose pharmacokinetics' mean?

It means the study is looking at how the body handles just one dose of the medicine – how it's absorbed, distributed, broken down, and leaves the body.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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