A study to assess how SAR443820 is absorbed, broken down and removed by the body in healthy adult men

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What is this study about?

This study is looking at amyotrophic lateral sclerosis, which is a condition that affects nerve cells in the brain and spinal cord, leading to loss of muscle control. The study will use an oral solution of SAR443820, which is a test medicine being developed. The medicine contains a special form called a microtracer that allows researchers to track how the body handles the medicine.

The purpose of this study is to find out how the body takes up, breaks down, and removes SAR443820 after it is given by mouth. Researchers want to understand how much of the medicine gets into the blood, how the body changes the medicine into other substances, and how these substances leave the body through urine and stool. They will also identify the main ways the body processes the medicine and the routes it uses to remove it from the body.

The study will involve healthy male adults between 18 and 55 years of age. Participants will receive a single dose of the medicine as a liquid taken by mouth. After taking the medicine, samples of blood, urine, and stool will be collected over a period of time to track how the medicine moves through the body. During the study, participants will have regular check-ups that include physical examinations, blood tests, and heart monitoring to ensure safety. The study will be conducted at a single center and is expected to last for a limited treatment period.

1 Screening and baseline assessment

Your health status will be evaluated through a medical history review, physical examination, laboratory tests, and an electrocardiogram (a test that records the electrical activity of your heart).

Your vital signs will be measured, including blood pressure, heart rate, and body temperature.

Blood and urine samples will be collected to check your kidney and liver function, as well as other laboratory parameters.

Your body weight and height will be measured to calculate your body mass index.

2 Admission to the clinical unit

You will be admitted to the clinical unit where the study will take place.

Additional baseline assessments may be performed before the medicine is given to you.

3 Administration of study medicine

You will receive a single oral dose of SAR443820 in the form of a liquid solution that you will take by mouth.

The medicine will contain a very small amount of a radioactive tracer called [14C]-SAR443820, which allows researchers to track how the medicine moves through your body.

This administration occurs only once during the study.

4 Sample collection period

After you take the medicine, blood samples will be collected at specific times to measure the levels of the medicine in your blood and plasma (the liquid part of your blood).

You will be asked to collect all urine and stool samples during your stay at the clinical unit. These samples will be used to measure how much of the medicine is removed from your body and to identify how your body breaks down the medicine.

The collection of samples will continue until researchers can determine the complete elimination of the medicine from your body.

5 Safety monitoring

Throughout your stay at the clinical unit, your health will be monitored continuously.

Your vital signs, including blood pressure and heart rate, will be measured regularly.

Electrocardiograms will be performed to monitor your heart’s electrical activity.

Blood samples will be taken to check your laboratory parameters, including kidney and liver function.

Any unwanted effects or symptoms you experience will be recorded and evaluated.

6 Discharge from the clinical unit

Once sufficient samples have been collected and researchers have determined that it is safe for you to leave, you will be discharged from the clinical unit.

Before discharge, a final assessment of your health status will be performed.

7 Follow-up assessment

After leaving the clinical unit, you may be asked to return for a follow-up visit to ensure your continued health and safety.

During this visit, your vital signs may be measured, and you may be asked about any symptoms or unwanted effects you have experienced since leaving the clinical unit.

Who Can Join the Study?

You must be a male between 18 and 55 years old at the time you sign the consent form to join the study
You must have regular bowel movements, meaning you have at least one bowel movement every 48 hours but no more than three bowel movements per day
You must be in good overall health based on your medical history, a physical examination, laboratory tests, and a heart tracing test called an ECG (a test that measures the electrical activity of your heart)
Your vital signs (measurements of basic body functions) must be within normal ranges after resting on your back for at least 5 minutes: your upper blood pressure number must be between 95 and 140, your lower blood pressure number must be between 45 and 90, and your heart rate must be between 45 and 100 beats per minute
Your ECG results must show normal heart activity after resting on your back for at least 5 minutes, with specific measurements being less than 120 milliseconds
Your laboratory test results must be within normal ranges or considered not medically important by the doctor; however, specific tests measuring kidney function and liver enzymes must not be more than 1.25 times the upper limit of normal
Your body weight must be between 60 and 90 kilograms, and your body mass index (a measure of body fat based on height and weight) must be between 18 and less than 30
You must agree to use contraception (birth control methods) during the study and for at least 90 days after taking the study medication: you must not donate sperm, and you must either avoid sexual intercourse with women or use a condom during sexual intercourse with women who could become pregnant
You must be able to understand and sign the informed consent form, which means you agree to participate and follow all study requirements and restrictions
Your kidney function must be normal, with a measurement called glomerular filtration rate (a test that shows how well your kidneys filter waste from your blood) greater than 90, calculated using a specific formula

Who Cannot Join the Study?

The study is only for male participants, so women cannot take part in this trial.
Participants must be healthy volunteers, meaning people who do not have any significant medical conditions or diseases.
This study involves giving a radioactive substance (a special form of the medication that can be tracked in the body), so people who have recently been exposed to radiation or who work with radiation may not be able to participate.
People with problems in their liver (the organ that helps clean your blood and break down medications) or kidneys (the organs that filter waste from your blood and make urine) likely cannot participate, as these organs are important for removing the medication from the body.
People who have trouble with bowel movements (passing stool regularly) may not be eligible, since the study needs to collect waste products to see how the medication leaves the body.
People taking other medications or supplements may not be able to join, as these could affect how the study medication works in the body.
People who have allergies (bad reactions) to similar medications or any ingredients in the study medication cannot participate.
People who smoke or use tobacco products may be excluded from the study.
People who drink alcohol regularly or use recreational drugs cannot participate.
People who have donated blood recently or plan to donate blood during the study period may not be eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Pqukbifezipvub Rkimumez Aqxqoinacy Ghpgf Blko	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	18.04.2023

Trial locations

Investigated drugs:

SAR443820

SAR443820 is an investigational medication being studied in this trial. Participants will receive a single dose by mouth. The medication contains a special form called a microtracer that includes a tiny amount of radioactive carbon (carbon-14) which allows researchers to track how the medication moves through the body, how it is broken down, and how it leaves the body through urine and stool.

Investigated diseases:

Amyotrophic lateral sclerosis

Amyotrophic Lateral Sclerosis – Amyotrophic lateral sclerosis is a disease that affects nerve cells in the brain and spinal cord responsible for controlling voluntary muscle movement. The disease causes these nerve cells to gradually break down and die over time. As the nerve cells deteriorate, the muscles they control become weaker and eventually stop working. The weakness typically begins in the hands, feet, or limbs and then spreads to other parts of the body. People with this condition progressively lose their ability to walk, speak, swallow, and breathe as the muscles become increasingly affected. The disease advances at different rates in different people, but it continuously worsens as more nerve cells are lost.

Trial ID:

2022-502534-23-00

Protocol code:

BEX17501

Trial Phase:

Human Pharmacology (Phase I) – Other

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A study to assess how SAR443820 is absorbed, broken down and removed by the body in healthy adult men

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?