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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002292-33 | |||
| U1111-1129-0248 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Primary Objective:
Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab SAR236553 (REGN727).
Secondary Objectives:
Total duration of the study per subject (excluding screening) is about 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alirocumab SAR236553 (REGN727) - mild hepatic function | Experimental | Injection through subcutaneous (SC) administration in patients with mild hepatic function |
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| alirocumab SAR236553 (REGN727) - moderate hepatic function | Experimental | Injection through subcutaneous (SC) administration in patients with moderate hepatic function |
|
| alirocumab SAR236553 (REGN727) - normal hepatic function | Experimental | Injection through subcutaneous (SC) administration in patients with normal hepatic function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alirocumab SAR236553 (REGN727) | Drug | alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9) Pharmaceutical form:Solution for injection Route of administration: subcutaneous |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727) | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of PK parameter - terminal elimination half-life (t1/2z) [ | Up to 12 weeks | |
| Assessment of PK parameter - apparent total body clearance (CL/F) | Up to 12 weeks | |
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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 |
|---|---|---|---|---|---|---|
| Investigational Site Number 250001 | Rennes | 35000 | France | |||
| Investigational Site Number 498001 |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C571059 | alirocumab |
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| Assessment of PK parameter - Distribution volume at the steady-state (Vss/F) |
| Up to 12 weeks |
| Assessment of PK parameter - time to maximum concentration (tmax) | Up to 12 weeks |
| Assessment of PK parameter - Mean Residence Time (MRT [area]) | Up to 12 weeks |
| Pharmacodynamics: Change in LDL-C from baseline | Up to 12 weeks |
| Number of participants with Adverse Events | Up to 12 weeks |
| Chisinau |
| 2025 |
| Moldova |
| D009750 |
| Nutritional and Metabolic Diseases |