Primary Objective: Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab SAR236553 (REGN727). Secondary Objectives: * Assess the safety and tolerability of alirocumab SAR236553 (REGN727) in patients with mild and moderate hepatic impairment and in matched subjects with normal hepatic function. * Assess the pharmacodynamic profile of alirocumab SAR236553 (REGN727) in patients with hepatic impairment and in matched subjects with normal hepatic function.
Total duration of the study per subject (excluding screening) is about 12 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
25
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
Investigational Site Number 250001
Rennes, France
Investigational Site Number 498001
Chisinau, Moldova
Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727)
Time frame: Up to 12 weeks
Assessment of PK parameter - terminal elimination half-life (t1/2z) [
Time frame: Up to 12 weeks
Assessment of PK parameter - apparent total body clearance (CL/F)
Time frame: Up to 12 weeks
Assessment of PK parameter - Distribution volume at the steady-state (Vss/F)
Time frame: Up to 12 weeks
Assessment of PK parameter - time to maximum concentration (tmax)
Time frame: Up to 12 weeks
Assessment of PK parameter - Mean Residence Time (MRT [area])
Time frame: Up to 12 weeks
Pharmacodynamics: Change in LDL-C from baseline
Time frame: Up to 12 weeks
Number of participants with Adverse Events
Time frame: Up to 12 weeks
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