amyotrophic lateral sclerosis (ALS)
Conditions
Brief summary
Primary endpoint: Pharmacokinetics Pharmacokinetic data will be summarized using descriptive statistics for each appropriate matrix. The results of other primary endpoint analyses of plasma and excreta samples collected to determine the metabolic pathways of SAR443820 and identify the chemical structures and main excretion routes of the main metabolites will be documented separately.
Detailed description
Safety analysis (adverse events [AEs], laboratory parameters, vital signs, and electrocardiograms [ECGs]) will be based on the review of individual values and descriptive statistics.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Pharmacokinetics Pharmacokinetic data will be summarized using descriptive statistics for each appropriate matrix. The results of other primary endpoint analyses of plasma and excreta samples collected to determine the metabolic pathways of SAR443820 and identify the chemical structures and main excretion routes of the main metabolites will be documented separately. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety analysis (adverse events [AEs], laboratory parameters, vital signs, and electrocardiograms [ECGs]) will be based on the review of individual values and descriptive statistics. | — |
Countries
Netherlands