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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolemia

Treatments: Drug: alirocumab SAR236553 (REGN727)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01670734

2012-002292-33

U1111-1129-0248 (Other Identifier)

POP12671

Details and patient eligibility

About

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.

Full description

Total duration of the study per subject (excluding screening) is about 12 weeks.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

alirocumab SAR236553 (REGN727) - mild hepatic function

Experimental group

Description:

Injection through subcutaneous (SC) administration in patients with mild hepatic function

Treatment:

Drug: alirocumab SAR236553 (REGN727)

alirocumab SAR236553 (REGN727) - moderate hepatic function

Experimental group

Description:

Injection through subcutaneous (SC) administration in patients with moderate hepatic function

Treatment:

Drug: alirocumab SAR236553 (REGN727)

alirocumab SAR236553 (REGN727) - normal hepatic function

Experimental group

Description:

Injection through subcutaneous (SC) administration in patients with normal hepatic function

Treatment:

Drug: alirocumab SAR236553 (REGN727)