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This is a randomized, placebo-controlled, four-part, Phase I, first in human (FIH) study to assess the tolerability and pharmacokinetics (PK) of ascending single and 14-day repeated oral doses of SAR442168 with a food effect investigation in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1a | Experimental | 3 single ascending doses of SAR442168 or placebo in fasted and fed (high-fat breakfast) conditions |
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| Part 1b | Experimental | 2 single doses of SAR442168 under fed conditions (moderate-fat breakfast). |
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| Part 1c | Experimental | 1 single dose of SAR442168 under fasting and fed conditions (high-fat breakfast). |
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| Part 1d | Experimental | 1 single dose of SAR442168 under fasting and fed conditions (Standardized high-fat breakfast). |
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| Part 2 | Experimental | 3 ascending once-daily repeated single doses of SAR442168 or placebo for 14 days under fed conditions (moderate-fat breakfast) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolebrutinib | Drug | Tablet, oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1a and Part 2: Number of participants with Adverse Events (AEs) and treatment-emergent adverse events (TEAEs) | Part 1a: Day 1 to approximately Day 14 Part 2: Day 1 to approximately Day 21 | |
| Part 1b: Total (free and bound) SAR442168 concentrations in CSF | From Day 1 to Day 3 | |
| Part 1b: Total (free and bound) SAR442168 metabolite(s) concentrations in CSF | From Day 1 to Day 3 | |
| Part 1c and Part 1d: Maximum plasma concentration observed (Cmax) ratio fed/fast of SAR442168 | From Day 1 to Day approximately 14 | |
| Part 1c and Part1d: Cmax ratio fed/fasted of SAR442168 metabolite(s) | From Day 1 to Day approximately 14 | |
| Part 1c and Part 1d: Area under the plasma concentration versus time curve (AUC) ratio fed/fast of SAR442168 | From Day 1 to Day approximately 14 | |
| Part 1c and Part1d: AUC ratio fed/fast of SAR442168 metabolite(s) | From Day 1 to Day approximately 14 |
| Measure | Description | Time Frame |
|---|---|---|
| All Parts: Cmax of SAR442168 | From Day 1 to Day approximately 14 | |
| All Parts: Cmax of SAR442168 metabolite(s) | From Day 1 to Day approximately 14 | |
| Part 1a, Part 1b and Part 2: tmax of SAR442168 |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's 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 |
|---|---|---|---|---|---|---|
| New Orleans Clinical Research Site Number : 8400001 | Knoxville | Tennessee | 37920 | 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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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Placebo | Drug | Tablet, oral |
|
| From Day 1 to Day approximately 14 |
| Part 1a, Part 1b and Part 2: tmax of SAR442168 metabolite(s) | From Day 1 to Day approximately 14 |
| Part 1a, Part 1b, Part1c and Part 1d: AUC of SAR442168 | From Day 1 to Day approximately 14 |
| Part 1a, Part 1b, Part1c and Part 1d: AUC of SAR442168 metabolite(s) | From Day 1 to Day approximately 14 |
| Part 2: AUC0-tau for SAR442168 | Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours) | From Day 1 to Day approximately 14 |
| Part 2: AUC0-tau for SAR442168 metabolite(s) | Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours) | From Day 1 to Day approximately 14 |
| Part 1b, Part1c and 1d: Number of participants with Adverse Events (AEs) and treatment-emergent adverse events (TEAEs) | From Day 1 to Day approximately 14 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |