Amyotrophic Lateral Sclerosis (Healthy Volunteers)
Conditions
Brief summary
Part 1: This is an open label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and period 2), 2-treatment crossover (between Treatment A and Treatment B for Part 1), study part to determine the relative bioavailability of SAR443820 in tablet formulation versus capsule formulation under fasted conditions. Two treatments are as follows: * Treatment A: SAR443820 - tablet formulation in fasted condition * Treatment B: SAR443820 - capsule formulation in fasted condition Each administration will be a single dose of SAR443820 separated by a wash out of at least 5 days. Part 2: This is an open-label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and period 2), 2-treatment crossover (between Treatment C and Treatment D for Part 2) study part to perform a preliminary assessment of the effect of a high-fat meal on pharmacokinetic parameters of single dose of SAR443820 in tablet formulation. Two treatments are as follows: * Treatment C: SAR443820 - tablet formulation in fasted condition * Treatment D: SAR443820 - tablet formulation in fed condition Each administration will be a single dose of SAR443820 separated by a wash out of at least 5 days. Participants are not allowed to participate in more than one part of the study. In both Parts 1 and 2, the assessment of pharmacokinetic, safety and tolerability are performed at each treatment period at baseline (prior single dosing) up to 48-hour postdosing in healthy adult male and female participants.
Detailed description
Screening period: up to 4 weeks (Day -28 to Day -2). In both Part 1 and Part 2: Period 1: Day -1 to Day 3 and 5 days wash out period. Period 2: Day -1 to Day 3 and until end-of-study visit at Day 6.
Interventions
DRUGSAR443820
Tablet by oral administration
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m\^2, inclusive * All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies * Having given written informed consent prior to undertaking any study-related procedure
Exclusion criteria
* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness * Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any non-live Covid-19 vaccine within the last 2 weeks before randomization, any live attenuated vaccine within the last 28 days before randomization and any other non-vaccine biological drugs given within 4 months before randomization * Positive result for hepatitis B, C or human immunodeficiency virus (HIV) * Positive result on urine drug screen * Positive urine alcohol test * Positive severe acute respiratory syndrom coronavirus 2 (SARS-CoV-2) test * Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 5 days before inclusion The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 2: Area under the plasma concentration (AUC) | In both Period 1 and Period 2: From Day 1 to Day 3 |
| Part 2: Area under the plasma concentration from time zero to the last concentration above the limit of quantification (AUClast) | In both Period 1 and Period 2: From Day 1 to Day 3 |
| Part 1: Area under the plasma concentration (AUC) | In both Period 1 and Period 2: From Day 1 to Day 3 |
| Part 1: Maximum plasma concentration observed (Cmax) | In both Period 1 and Period 2: From Day 1 to Day 3 |
| Part 2: Maximum plasma concentration observed (Cmax) | In both Period 1 and Period 2: From Day 1 to Day 3 |
| Part 1: Area under the plasma concentration from time zero to the last concentration above the limit of quantification (AUClast) | In both Period 1 and Period 2: From Day 1 to Day 3 |
Secondary
| Measure | Time frame |
|---|---|
| Part 2: Number of participants with treatment emergent adverse events (TEAEs) | In both Period 1 and Period 2: From Day 1 to Day 4 |
| Part 1: Number of participants with treatment emergent adverse events (TEAEs) | In both Period 1 and Period 2: From Day 1 to Day 4 |
Countries
United States
Outcome results
None listed