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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1287-6944 | Registry Identifier | ICTRP |
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This is a cross-over, Phase 1, 3-treatment period single sequence study. The purpose of this study is to characterize pharmacokinetics (PK), safety, and tolerability of single ascending oral doses of SAR441566 in healthy male Japanese participants, 18-55 years of age.
The duration of the study for a participant will be up to approximately 65 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR441566 | Experimental | Participants will receive single ascending doses of SAR441566 on day 1 of each 8-12-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR441566 | Drug | Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: Cmax | Maximum plasma concentration observed | From Day 1 to Day 5 of each period (5 days per period) |
| Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUClast | Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time Tlast (AUClast) | From Day 1 to Day 5 of each period (5 days per period) |
| Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUC | Area under the plasma concentration versus time curve extrapolated to infinity (AUC) | From Day 1 to Day 5 of each period (5 days per period) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AE) and treatment-emergent adverse events (TEAEs) | Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including Serious AE and AE of Special Interest | Up to end of study visit (which will occur at latest day 37 of study) |
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Inclusion Criteria:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
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 |
|---|---|---|---|---|---|---|
| Parexel International-Site Number:8400001 | Glendale | California | 91206 | United States |
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| Label | URL |
|---|---|
| PKM17860 Plain Language Results Summary | View source |
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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 |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |