Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects

Sponsor
Sanofi
Study ID
NCT01723735
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Alirocumab — DRUG
    Pharmaceutical form: solution for injection Route of administration: subcutaneous
  • Ezetimibe — DRUG
    Pharmaceutical form: overencapsulated tablet Route of administration: oral
  • Ezetimibe Placebo — DRUG
    Pharmaceutical form: capsule Route of administration: oral
  • Fenofibrate — DRUG
    Pharmaceutical form: tablet Route of administration: oral

Study Details

Primary Objective: To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol (LDL-C). Secondary Objectives: * To assess the pharmacodynamic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate, based on other lipid parameters. * To assess the pharmacokinetic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate.

Key Dates

Start date
Nov 30, 2012
Status verified
Sep 2016
Primary completion
Jul 31, 2013
Completion
Jul 31, 2013

Study Design

Enrollment
79 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Alirocumab + Ezetimibe Placebo
    Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe placebo
  • Experimental: Alirocumab + Ezetimibe
    Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe
  • Experimental: Alirocumab + Fenofibrate
    Subcutaneous (SC) injections of alirocumab added to oral administration of fenofibrate

Primary Outcome Measure

Assessment of the effect of alirocumab on LDL-C [ Time Frame: Up to 18 weeks ]

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