#1 Clinical Trials Search in Europe

SAR443820

Clinical trials are investigating SAR443820 to learn how it behaves in the body and to measure key study results such as pharmacokinetics. The available trial data include healthy adult men and focus on amyotrophic lateral sclerosis (ALS)-related research. These studies help researchers understand absorption, breakdown, removal, and excretion patterns.

Table of Contents

Trial overview

The available clinical trial for SAR443820 is an interventional study, which means researchers gave the study medicine and then measured what happened in the body.[1] The study was completed and enrolled 6 people.[1]

The trial title says it studied how much test medicine SAR443820 is taken up, broken down, and removed by the body when given in a liquid form by mouth.[1]

Study participants and target population

This study enrolled healthy male adult participants.[1] The trial data also list amyotrophic lateral sclerosis, or ALS, as the condition connected to the research record.[1]

Because the source data only describe the enrolled group as healthy adult men, the trial was not testing SAR443820 in people with ALS in this specific study record.[1]

Study design and phase

The study was in Phase 1, which is an early clinical trial stage.[1] Phase 1 trials often focus on how a study medicine behaves in the body rather than on whether it helps a disease.[1]

The trial used oral administration in a liquid form, meaning the medicine was given by mouth as a liquid.[1] The source also notes that [14C]-SAR443820 was used, and samples were collected from blood and body waste to study the medicine in the body.[1]

What the trial measured

The main outcome was pharmacokinetics, which describes how a medicine is absorbed, distributed, broken down, and removed by the body.[1] The results were to be summarized with descriptive statistics, meaning simple numbers and summaries rather than a complex comparison test.[1]

The trial also aimed to determine the excretion balance after oral administration of [14C]-SAR443820 in healthy male participants.[1] In simple terms, this means researchers wanted to see how much of the study medicine left the body and by what routes.[1]

Another goal was to collect plasma and excreta samples to identify the metabolic pathways and the chemical structures and main excretion routes of the main metabolites.[1] Metabolites are the substances formed when the body processes a medicine.[1]

What the results help researchers learn

This trial helps researchers understand how SAR443820 moves through the body in healthy adults.[1] Information from blood, plasma, and waste samples can help show where the study medicine goes, how it changes, and how it is removed.[1]

Because the study was completed and small, with only 6 participants, it appears to be an early research step rather than a large effectiveness trial.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2022-502534-23-00Phase 1ALSCompleted6

FAQ

  • What is being studied in the SAR443820 trials? The trials are studying how SAR443820 is taken up, broken down, and removed by the body. They also measure excretion balance and metabolic pathways.
  • Who took part in the available SAR443820 study? The listed study enrolled healthy male adult participants. The trial data do not show a patient group with ALS taking part in this study.
  • What phase is the SAR443820 study? The available trial is a Phase 1 study. Phase 1 studies are early trials that mainly look at how a study medicine behaves in the body.
  • What condition is linked to SAR443820 in the trial data? The condition listed in the trial data is amyotrophic lateral sclerosis, also called ALS. However, the specific study described was done in healthy male adults.
  • What results are the researchers measuring? The main result is pharmacokinetics, which means how the body absorbs, moves, breaks down, and removes the study medicine. The study also looks at metabolites, which are the substances made when the body processes the medicine.

Ongoing Clinical Trials on SAR443820

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

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Amyotrophic lateral sclerosis (ALS): A serious disease that affects nerve cells and can cause muscle weakness over time.
  • Adult participants: People who are old enough to join adult research studies.
  • Healthy volunteers: People without the disease being studied who join a trial to help researchers collect basic study data.
  • Phase 1: An early stage of clinical research that usually checks how a study medicine behaves in the body.
  • Interventional study: A trial in which researchers give a study treatment and then measure the results.
  • Pharmacokinetics: The study of how a medicine is absorbed, moved through the body, broken down, and removed.
  • Excretion balance: A measure of how much of the study medicine leaves the body through urine, stool, or other waste.
  • Metabolic pathways: The steps the body uses to change a medicine into other substances.
  • Metabolites: Substances made when the body breaks down a medicine.
  • Plasma: The liquid part of blood that carries cells and many other substances.
  • Excreta: Body waste such as urine and stool.

References

  1. https://clinicaltrials.gov/study/2022-502534-23-00