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

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01723735
First received: November 6, 2012
Last updated: August 26, 2014
Last verified: August 2013
  Purpose

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 SAR236553 (REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on other lipid parameters.

To assess the pharmacokinetic profile of alirocumab SAR236553 (REGN727) administered either alone or on top of ezetimibe or fenofibrate.


Condition Intervention Phase
Hypercholesterolemia
Drug: alirocumab SAR236553 (REGN727)
Drug: ezetimibe
Drug: ezetimibe placebo
Drug: fenofibrate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Randomized, Partial Blind, 3 Parallel Groups Study of the Pharmacodynamic Profile of SAR236553 (REGN727) Administered as Multiple Subcutaneous Doses, Either Alone or on Top of Ezetimibe or Fenofibrate Administered as Multiple Oral Doses in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Assessment of the effect of alirocumab SAR236553 (REGN727) on LDL-C [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the pharmacodynamic profile of alirocumab SAR236553 (REGN727) [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727) [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Assessment of serum concentrations of PCSK9 [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: November 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alirocumab SAR236553 (REGN727)+ ezetimibe placebo

Oral administration of ezetimibe placebo and injections of alirocumab SAR236553 (REGN727) through subcutaneous (SC) administration

alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9

Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution for injection Route of administration: subcutaneous
Drug: ezetimibe placebo
Pharmaceutical form:capsule Route of administration: oral
Experimental: alirocumab SAR236553 (REGN727)+ ezetimibe
Oral administration of ezetimibe and injections of alirocumab SAR236553 (REGN727) through subcutaneous (SC) administration
Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution for injection Route of administration: subcutaneous
Drug: ezetimibe
Pharmaceutical form:overencapsulated tablet Route of administration: oral
Experimental: alirocumab SAR236553 (REGN727)+ fenofibrate
Oral administration of fenofibrate and injections of alirocumab SAR236553 (REGN727) through subcutaneous (SC) administration - Type: Experimental
Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution for injection Route of administration: subcutaneous
Drug: fenofibrate
Pharmaceutical form:tablet Route of administration: oral

Detailed Description:

Total duration of the study per subject (excluding screening) is about 22 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria :

  • Healthy male /or female subjects,
  • aged 18 to 65 years old,
  • with LDL-C > 130 mg/dL
  • not receiving lipid lowering therapy.

Exclusion criteria:

  • Healthy subjects with history or presence of clinically relevant illness.
  • Subjects currently taking statins, ezetimibe or fenofibrate.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723735

Locations
France
Investigational Site Number 250001
Rennes, France, 35000
Investigational Site Number 250002
Rueil Malmaison, France, 92502
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01723735     History of Changes
Other Study ID Numbers: PKD12910, U1111-1131-3203, 2012-003049-13
Study First Received: November 6, 2012
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Fenofibrate
Anticholesteremic Agents
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014