Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects

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.

Inclusion criteria :

• Male or female, between 18 to 75 years of age, inclusive.
• Patients with mild and moderate hepatic impairment based on Child-Pugh score and stable chronic liver disease.
• Healthy subjects with normal hepatic function.

Exclusion criteria:

• Patients with acute hepatitis, hepatic encephalopathy grade 2, 3, and 4.
• Patients with history or presence of uncontrolled clinically relevant illness.
• Healthy subjects with history or presence of clinically relevant illness.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.