Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects

Study Overview
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Brief Summary
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Primary Objective: To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol (LDL-C). Secondary Objectives: To assess the pharmacodynamic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate, based on other lipid parameters. To assess the pharmacokinetic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate.

Detailed Description
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Total duration of the study per subject (excluding screening) is about 22 weeks.

Official Title
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A Randomized, Partial Blind, 3 Parallel Groups Study of the Pharmacodynamic Profile of SAR236553 (REGN727) Administered as Multiple Subcutaneous Doses, Either Alone or on Top of Ezetimibe or Fenofibrate Administered as Multiple Oral Doses in Healthy Subjects

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Alirocumab
* Drug: Ezetimibe
* Drug: Ezetimibe Placebo
* Drug: Fenofibrate


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Healthy male /or female subjects, aged 18 to 65 years old, with LDL-C > 130 mg/dL not receiving lipid lowering therapy. Exclusion criteria: Healthy subjects with history or presence of clinically relevant illness. Subjects currently taking statins, ezetimibe or fenofibrate. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alirocumab + Ezetimibe Placebo<br>Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe placebo | Drug: Alirocumab<br>* Pharmaceutical form: solution for injection Route of administration: subcutaneous<br>* Other names: REGN727;Drug: Ezetimibe Placebo<br>* Pharmaceutical form: capsule Route of administration: oral<br>|
| Experimental: Alirocumab + Ezetimibe<br>Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe | Drug: Alirocumab<br>* Pharmaceutical form: solution for injection Route of administration: subcutaneous<br>* Other names: REGN727;Drug: Ezetimibe<br>* Pharmaceutical form: overencapsulated tablet Route of administration: oral<br>|
| Experimental: Alirocumab + Fenofibrate<br>Subcutaneous (SC) injections of alirocumab added to oral administration of fenofibrate | Drug: Alirocumab<br>* Pharmaceutical form: solution for injection Route of administration: subcutaneous<br>* Other names: REGN727;Drug: Fenofibrate<br>* Pharmaceutical form: tablet Route of administration: oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the effect of alirocumab on LDL-C |  | Up to 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the pharmacodynamic profile of alirocumab |  | Up to 18 weeks | 
| Pharmacokinetics: Assessment of serum concentrations of alirocumab |  | Up to 18 weeks | 
| Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9) |  | Up to 18 weeks |