Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1, open-label, single-center study to determine the absorption, distribution, metabolism, and excretion of a single oral dose of SAR443820 containing microtracer [14C]-SAR443820 in healthy male participants

Researchers are conducting a study to understand what happens to a new drug called SAR443820 when it enters the body. They are particularly interested in how the body takes in, uses, and eventually removes the drug. This type of research is a very early step in developing new medicines, and it helps scientists learn more about how a drug works. This specific study is being done on healthy men and uses a tiny, safe tracing substance with the drug to track its journey. The drug is being developed for people with Amyotrophic Lateral Sclerosis (ALS), a serious condition that affects nerves and muscles, but this study focuses on understanding the drug's basic behaviour in the body.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Sanofi-Aventis Research & Development

Enrolment target

Start

02 May 2023

amyotrophic lateral sclerosis (ALS)

What is this study about?

This research study is about a new medicine called SAR443820. Its main purpose is to carefully watch what happens to this drug when a healthy man takes it. Think of it like this: when you eat food, your body breaks it down, uses what it needs, and gets rid of the rest. This study wants to understand that same process for SAR443820 – how it's absorbed into the blood, where it goes in the body, how the body changes it, and finally, how the body gets rid of it. This detailed understanding is really important for developing new medicines safely and effectively.

To do this, the study uses a very small, safe amount of a special tracing substance (almost like a tiny, invisible tag) added to SAR443820. This allows researchers to follow the drug's path through the body more easily. They will collect blood and body waste samples to track the drug's journey and see how it breaks down and what its main parts are when it leaves the body.

While this particular drug, SAR443820, is being developed for people with a condition called Amyotrophic Lateral Sclerosis (ALS) – a serious illness that affects nerves and muscles – this study is conducted in healthy men. This is a common first step in drug development to ensure the drug behaves as expected and to gather basic safety information before testing it in patients with the illness. The results from this study will help guide future research into SAR443820 for ALS.

Key takeaways

This is an early-stage study about a new drug, SAR443820, for ALS.
It aims to understand how the drug is processed by the body in healthy men.
Participation involves taking a single dose of the drug and undergoing health monitoring.
Your contribution helps advance medical research, but there are no direct health benefits to you.
The study prioritises your safety and allows you to withdraw at any time.

Who may be eligible?

This study is specifically looking for healthy male volunteers. You must be at least 18 years old to consider taking part. There's no upper age limit mentioned, so older men might also be able to join, as long as they are healthy.

Being 'healthy' means you shouldn't have any major ongoing health problems. The study team will check your health very carefully to make sure you are suitable and that taking part would be safe for you. They will review your medical history and conduct tests to confirm your general good health.

If you are a woman, you would not be able to participate in this particular study, as it's designed only for men. Similarly, if you have certain medical conditions or are taking specific medications, you might not be eligible. The study team will provide full details 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.

Are you male?
Are you 18 years old or older?
Are you generally in good health?
Are you able to visit a research centre as required?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will visit a special research centre. You will be given a single dose of the study drug, SAR443820. This drug will contain a tiny, safe tracing substance to help researchers track it in your body. Throughout your participation, healthcare professionals will carefully monitor you. They will take blood samples and collect other body waste to see how the drug is absorbed, moves through, and leaves your body. They will also do regular health checks, such as measuring your vital signs (like blood pressure and heart rate), taking electrocardiograms (ECGs) to check your heart, and doing laboratory tests to monitor your general health. The exact number of visits, how long each visit lasts, and the total time you would be involved in the study would be explained in detail by the research team. You would likely need to stay at the research centre for a period after taking the drug to allow for comprehensive monitoring and sample collection.

Potential risks and benefits

Participating in research studies like this helps scientists learn more about new drugs, which could eventually lead to important treatments for serious conditions like ALS. While there's no direct health benefit to you from taking this drug, your contribution is very valuable to medical science. As with any medicine, there's always a chance of side effects, though early-stage studies like this carefully monitor for any problems. You'll be closely watched by medical staff, and they will explain all known or potential risks to you. Remember, you can choose to leave 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 ALS?

ALS stands for Amyotrophic Lateral Sclerosis. It's a serious illness that damages nerve cells in the brain and spinal cord, leading to muscle weakness and problems with movement.

Why are only men included in this study?

Early studies sometimes focus on one gender to simplify the initial understanding of how a drug works in the body and its safety. Future studies might include women.

What does 'single oral dose' mean?

It means you would take the drug by mouth, just once, during the study.

What is a 'microtracer'?

It's a very tiny, safe amount of a special substance added to the drug. It acts like a marker, helping scientists track where the drug goes in your body without causing harm.

Will I get paid for taking part?

Payment for participation or reimbursement for travel expenses is common in research studies for healthy volunteers, but you will need to confirm this with the study team.