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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1256-9220 | Registry Identifier | ICTRP |
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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:
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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Single dose of SAR443820 tablet in fasted condition |
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| Treatment B | Experimental | Single dose of SAR443820 capsule in fasted condition |
|
| Treatment C | Experimental | Single dose of SAR443820 tablet in fasted condition |
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| Treatment D | Experimental | Single dose of SAR443820 tablet in fed condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR443820 | Drug | Tablet by oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 2: Area under the plasma concentration (AUC) | In both Period 1 and Period 2: From Day 1 to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of participants with treatment emergent adverse events (TEAEs) | In both Period 1 and Period 2: From Day 1 to Day 4 | |
| Part 2: Number of participants with treatment emergent adverse events (TEAEs) | In both Period 1 and Period 2: From Day 1 to Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prism Research-Site Number:8400001 | Saint Paul | Minnesota | 55144 | United States |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| SAR443820 | Drug | Capsule by oral administration |
|
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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