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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal

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.