Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase I, open-label, non-randomized study to evaluate the absorption, distribution, metabolism and excretion and pharmacokinetics of DLX313 (minzasolmin) following a single oral dose of [14C]DLX313 in healthy male participants

This study is looking at a new medicine called DLX313, which might one day help people with Parkinson's Disease. For this first step, healthy men will receive a single dose of the drug. The main goal is to understand how the body handles DLX313: how much is absorbed, where it goes, how it's changed, and how it leaves the body. This helps scientists learn about the drug's safety and how it works in humans. Because it's an early-stage study, it focuses on these basic body processes rather than directly treating Parkinson's right now. This vital information helps decide if the medicine can be tested further in people actually living with Parkinson's.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Novartis Pharma AG

Enrolment target

Start

16 Jul 2024

Parkinson’s Disease

What is this study about?

This study is a very early step in testing a new medicine called DLX313. Think of it like taking a new car for its first test drive – not to win a race, but just to see how all the basic parts work. Researchers want to understand how this medication behaves inside the human body. They will give a single dose of DLX313 to healthy male volunteers and then carefully watch how it's absorbed from the gut, where it goes in the body, how the body processes it, and finally, how it's removed. This is often called studying the 'pharmacokinetics' of a drug.

The reason for doing this study is to gather important information about DLX313 that will help scientists decide if it's safe and worth developing further. This particular drug is being investigated because it holds potential for treating Parkinson's Disease. However, this specific study is not designed to treat Parkinson's; it's purely to understand the drug's journey through the body.

By understanding these fundamental processes, researchers can work out the best way to give the drug, how often, and in what doses, for future studies involving people with Parkinson's. It's a crucial stepping stone to developing new and better treatments.

Key takeaways

This is an early-stage study (Phase I) in healthy men.
It aims to understand how the body handles a new potential Parkinson's drug, DLX313.
The study involves a single dose of the medicine.
Participation will include multiple visits and medical checks.
It will not treat Parkinson's but will help future research.
You have the right to withdraw at any time.

Who may be eligible?

This study is looking for healthy men to take part. To be eligible, you need to be at least 18 years old. There isn't an upper age limit mentioned, but you would still need to be in generally good health.

Being healthy means you don't have any major ongoing medical conditions that could affect how the drug works or your safety during the study. The researchers will perform checks to make sure you are suitable.

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 man?
Are you 18 years old or older?
Are you generally considered healthy by a doctor?
Do you understand this study is not for treating a disease?
Are you able to attend several clinic appointments?

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, DLX313. Because this is an early study to understand how your body handles the drug, you would likely need to visit the study clinic multiple times. These visits will involve various tests, such as blood and urine samples, to track the medicine's journey through your system.

The researchers will monitor you closely after you take the medicine to check for any effects. You might stay at the clinic for a period after taking the dose, and then return for follow-up appointments over a certain number of days or weeks. The total length of your involvement, from your first screening visit to your final check-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this might offer a chance to contribute to medical research, potentially helping find new treatments for Parkinson's Disease in the future. However, there are also potential risks involved, mainly from taking a new medicine for the first time. You might experience side effects, some of which may be unknown. The study team will explain all known or expected risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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 Parkinson's Disease?

Parkinson's Disease is a long-term condition that affects the brain, causing problems with movement like shaking, stiffness, and slow movement.

What does a 'Phase I' study mean?

Phase I is the first stage of testing a new medicine in humans. It focuses on safety and understanding how the drug works in the body, rather than directly treating a disease.

Why are only men included in this study?

Often, in the very early stages of testing a new drug, studies might focus on one sex to simplify the initial safety data. Future studies will likely include women.

Will this medicine help my Parkinson's?

No, this specific study is not designed to treat Parkinson's Disease. It's an early safety study in healthy volunteers to gather information for future research.

Will I get paid to participate?

Many early-stage clinical trials offer some payment for your time and inconvenience. The study team will provide details on this.