Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Pilot Open-label, Randomized, Crossover, Comparative Bioavailability Study of Levodopa Administered via Levodopa Cyclops™ (test product) Relative to INBRIJA® (reference product) in Healthy Adult Subjects

This early-stage study is looking at a new inhaled medicine called Levodopa Cyclops™. It contains levodopa, a common medicine for Parkinson's disease. The study aims to compare how the body absorbs this new inhaler versus an already approved inhaler called INBRIJA®. Researchers want to understand how quickly and how much levodopa gets into the blood when given by these different methods. This information will help decide if the new inhaler could be a good option for people with Parkinson's in the future, particularly for sudden worsening of symptoms. This specific study is being done in healthy volunteers, not Parkinson's patients, to understand the basic drug absorption.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

CCDRD Cooperative Clinical Drug Research and Development AG, PureIMS B.V.

Enrolment target

Start

15 Aug 2023

What is this study about?

This study is a very early step in developing a new way to give a medicine called levodopa. Levodopa is a key treatment for Parkinson's disease. Currently, people with Parkinson's sometimes experience sudden return of their symptoms, known as 'OFF periods,' even when taking their regular medication. The idea behind this new inhaled version of levodopa (called Levodopa Cyclops™) is to provide quick relief during these 'OFF periods'.

Think of it like this: if you have a headache, you might take a pill, but sometimes you need medicine that works faster. This new inhaler is being explored as a quick-acting option for Parkinson's symptoms. This particular study isn't testing whether it treats Parkinson's itself – that comes much later. Instead, it's focused on understanding how the new inhaler works inside the body.

The main goal is to compare how quickly and how much of the levodopa medicine gets into the bloodstream when given by the new Levodopa Cyclops™ inhaler compared to an existing, approved inhaler called INBRIJA®. Researchers will be measuring things like the highest level of medicine in the blood, how long it takes to reach that level, and how long the medicine stays in the body. This information is crucial for understanding if Levodopa Cyclops™ could potentially be a useful treatment for people with Parkinson's disease in the future. Because this is an early study to understand how the medicine behaves in the body, it's being conducted in healthy adult volunteers, not people with Parkinson's.

Key takeaways

This study is testing a new inhaled Parkinson's medicine called Levodopa Cyclops™.
It's comparing how the new inhaler works in the body compared to an existing one, INBRIJA®.
The study is for healthy adult volunteers, not people with Parkinson's.
It aims to understand how quickly and efficiently the body absorbs the medicine.
This is an early step in researching potential new treatments for Parkinson's 'OFF periods'.

Who may be eligible?

To join this study, everyone must be at least 18 years old. There's no upper age limit, meaning older adults can also take part if they meet other health requirements.

Since this is an early study testing how a medicine acts in the body, it's open to both men and women. The most important thing is that participants are healthy. This means you should not have any serious medical conditions that could affect how your body handles the study medications or interfere with the study results. The research team will conduct thorough health checks to make sure you're suitable and safe to participate.

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 18 years old or older?
Are you generally healthy with no serious existing medical conditions?
Are you available for multiple clinic visits over a period of time?
Are you comfortable with regular blood tests and health checks?
Are you willing to use an inhaler as directed by the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive two different inhaled medicines: Levodopa Cyclops™ and INBRIJA®. You wouldn't take them at the same time, but in a specific order, as directed by the study team. This type of study often involves several visits to a clinic over a period of time. During these visits, you'd have blood samples taken regularly after using the inhalers to measure the levels of levodopa in your body. You would also have routine health checks, such as blood pressure, heart rate, and temperature, and provide urine samples. The study team would also ask you about any side effects you might experience. The total duration of your participation, including all visits and follow-up, would be fully explained to you before you agree to join.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of taking part is contributing to medical science, which could help develop new treatments for Parkinson's disease in the future. As this is an early-stage study in healthy volunteers, you are not expected to receive a direct health benefit. Potential risks might include discomfort from blood draws, temporary side effects from the inhaled medications (such as cough or throat irritation), or other unexpected reactions, though serious side effects are carefully monitored and rare in early-stage studies. 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
Bulgaria

Common questions

What is levodopa?

Levodopa is a common medicine used to treat Parkinson's disease by helping to replace a natural chemical in the brain called dopamine.

Why is this study using healthy volunteers instead of people with Parkinson's?

This is an early 'Phase 1' study focused on how the body handles the medicine. Using healthy volunteers helps researchers understand the basic absorption and safety before testing it in patients with the condition.

Will I be given the Levodopa Cyclops™ or INBRIJA® first?

The study design is 'crossover,' meaning you will receive both, but the order in which you get them will be randomly decided, like flipping a coin, to ensure fair comparison.

What are 'OFF episodes'?

In Parkinson's disease, 'OFF episodes' are when medications wear off, and symptoms like slowness, stiffness, and tremor return or worsen.

Will I get paid for taking part?

Compensation for time and travel is often provided in early-stage studies. The research team will explain any payments clearly.