Hypercholesterolemia Clinical Trial
Official title:
An Open-Label, Pharmacokinetic and Tolerability Study of SAR236553/REGN727 Given as a Single SC Dose in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function
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. ;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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