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

Sponsor
Sanofi
Study ID
NCT01670734
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • alirocumab SAR236553 (REGN727) — DRUG
    alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9) Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Study Details

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.

Key Dates

Start date
Sep 30, 2012
Status verified
Jun 2013
Primary completion
May 31, 2013
Completion
May 31, 2013

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: alirocumab SAR236553 (REGN727) - mild hepatic function
    Injection through subcutaneous (SC) administration in patients with mild hepatic function
  • Experimental: alirocumab SAR236553 (REGN727) - moderate hepatic function
    Injection through subcutaneous (SC) administration in patients with moderate hepatic function
  • Experimental: alirocumab SAR236553 (REGN727) - normal hepatic function
    Injection through subcutaneous (SC) administration in patients with normal hepatic function

Primary Outcome Measure

Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727) [ Time Frame: Up to 12 weeks ]

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