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.
Total duration of the study per subject (excluding screening) is about 22 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
79
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form: overencapsulated tablet Route of administration: oral
Pharmaceutical form: capsule Route of administration: oral
Investigational Site Number 250001
Rennes, France
Investigational Site Number 250002
Rueil-Malmaison, France
Assessment of the effect of alirocumab on LDL-C
Time frame: Up to 18 weeks
Assessment of the pharmacodynamic profile of alirocumab
Time frame: Up to 18 weeks
Pharmacokinetics: Assessment of serum concentrations of alirocumab
Time frame: Up to 18 weeks
Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9)
Time frame: Up to 18 weeks
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Pharmaceutical form: tablet Route of administration: oral