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

Phase 1

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: alirocumab SAR236553 (REGN727)

• Registration Number: NCT01670734
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-22
• Study Start: 2012-09
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-27
• Last Update Posted: 2013-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alirocumab SAR236553 (REGN727) - normal hepatic function	alirocumab SAR236553 (REGN727)	Injection through subcutaneous (SC) administration in patients with normal hepatic function
alirocumab SAR236553 (REGN727) - moderate hepatic function	alirocumab SAR236553 (REGN727)	Injection through subcutaneous (SC) administration in patients with moderate hepatic function
alirocumab SAR236553 (REGN727) - mild hepatic function	alirocumab SAR236553 (REGN727)	Injection through subcutaneous (SC) administration in patients with mild hepatic function

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727)	Up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Assessment of PK parameter - apparent total body clearance (CL/F)	Up to 12 weeks
Assessment of PK parameter - Distribution volume at the steady-state (Vss/F)	Up to 12 weeks
Assessment of PK parameter - time to maximum concentration (tmax)	Up to 12 weeks
Assessment of PK parameter - Mean Residence Time (MRT [area])	Up to 12 weeks
Pharmacodynamics: Change in LDL-C from baseline	Up to 12 weeks
Number of participants with Adverse Events	Up to 12 weeks
Assessment of PK parameter - terminal elimination half-life (t1/2z) [	Up to 12 weeks

Trial Locations

Locations (2)

Investigational Site Number 250001; 🇫🇷 Rennes, France

Investigational Site Number 498001; 🇲🇩 Chisinau, Moldova, Republic of