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Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A study to compare the absorption of two tablet strengths with the absorption of a solution.

This study is designed to understand how a specific medicine for Parkinson's disease is taken up by the body. Researchers want to compare two different tablet strengths (amounts of medicine) with a liquid version of the same medicine. Essentially, they want to see if the tablets and the liquid deliver the medicine to your system in a similar way. This is an early stage of research, sometimes called a 'Phase I' trial. It's about checking how the medicine behaves in people, rather than testing if it treats the disease. It helps doctors choose the best way to give the medicine in the future. Anyone aged 18 or over, male or female, can potentially take part if they have Parkinson's disease.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Bioequivalence Study
Sponsor
Arvinas Operations Inc.
Enrolment target
18
Start
27 Feb 2025

What is this study about?

This research is focused on understanding how a medicine for Parkinson's disease travels through your body. Think of it like this: when you take a medicine, your body needs to absorb it so it can start working. This study is specifically looking at how well two different strengths of a tablet (meaning two different amounts of the medicine in pill form) are absorbed, compared to a liquid form of the very same medicine.

The main goal is to see if your body absorbs the tablets in a similar way to the liquid, and if the different tablet strengths are absorbed as expected. This type of study is an early but very important step in developing new or improved medicines. It helps scientists and doctors figure out the best way to give a medicine so it works effectively once more advanced studies begin.

It's important to know that this study isn't about testing if the medicine treats Parkinson's disease itself in this specific trial. Instead, it's about the basic science of how the medicine gets into your system. By understanding this, researchers can make better decisions about how to make and deliver medicines for people with Parkinson's disease in the future.

Key takeaways

  • Study compares how two tablet strengths and a liquid medicine are absorbed.
  • It's for people with Parkinson's disease.
  • This is an early stage (Phase I) study, focused on how the medicine works in the body.
  • Not primarily testing if the medicine treats the disease.
  • Participation involves clinic visits, blood tests, and monitoring.
  • You must be 18 or older to take part.

Who may be eligible?

To be considered for this study, you need to have been diagnosed with Parkinson's disease. The study is open to both men and women.

In terms of age, you must be at least 18 years old. There isn't an upper age limit mentioned, but other health factors will likely be checked to make sure it's safe for you to take part.

The research team will review your medical information to see if you meet all the specific requirements. These unmentioned details might include things like other health conditions you have, medicines you're currently taking, or specific lab test 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.

  1. Do I have a diagnosis of Parkinson's disease?
  2. Am I 18 years old or older?
  3. Am I male or female (both are welcome)?
  4. Am I able to visit the study clinic regularly, if needed?
  5. Am I willing to have blood tests?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either a tablet form (one of two strengths) or a liquid form of the study medicine. You won't know which one you're getting at specific times, as the study is designed to compare them. Taking part would likely involve several visits to a clinic or hospital where the research team will monitor you closely.

During these visits, assessments would be made. This usually includes having blood samples taken to measure how much of the medicine is in your system. You might also have your vital signs (like blood pressure and heart rate) checked, and answer questions about how you're feeling. The study will involve a follow-up period after you've taken the medicine.

The total amount of time you would be involved in the study – from the first screening visit to the final follow-up – will be explained fully by the study team. This type of trial often involves relatively short but intensive visits.

Potential risks and benefits

Potential benefits of taking part in this study include contributing to a better understanding of how medicines for Parkinson's disease work, which could help future patients. You would also receive careful medical monitoring during your participation. Potential risks could include side effects from the study medicine, discomfort from blood draws, or the time commitment involved. However, the study team will fully explain all known risks before you make a decision. Remember, you can choose 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 'absorption' in this study?

Absorption means how well your body takes in the medicine after you've swallowed it, so it can start working.

What does 'Phase I' mean for a study?

Phase I is an early stage of research, focusing on how a medicine behaves in the body, its safety, and how it's absorbed, rather than if it treats a disease.

Will this study cure my Parkinson's?

No, this study is highly unlikely to cure Parkinson's disease. Its aim is to understand how the medicine is absorbed, not to treat the condition itself at this stage.

Do I have to stop my current Parkinson's medication?

This is a very important question to ask the study team. They will tell you exactly what medicines you can and cannot take while in the study.

How long would I need to be involved?

The total duration of your participation, including all visits and follow-ups, will be clearly explained by the research team if you are eligible.

How to find out more

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

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