Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: September 27, 2016
Last verified: September 2016
  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 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.

Condition Intervention Phase
Hypercholesterolemia
Drug: Alirocumab
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 on LDL-C [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the pharmacodynamic profile of alirocumab [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Assessment of serum concentrations of alirocumab [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9) [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]

Enrollment: 79
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 + Ezetimibe Placebo
Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe placebo
Drug: Alirocumab

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR236553
  • REGN727
Drug: Ezetimibe Placebo

Pharmaceutical form: capsule

Route of administration: oral

Experimental: Alirocumab + Ezetimibe
Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe
Drug: Alirocumab

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR236553
  • REGN727
Drug: Ezetimibe

Pharmaceutical form: overencapsulated tablet

Route of administration: oral

Experimental: Alirocumab + Fenofibrate
Subcutaneous (SC) injections of alirocumab added to oral administration of fenofibrate
Drug: Alirocumab

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR236553
  • REGN727
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   (Adult)
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

Publications:
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: September 27, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Ezetimibe
Fenofibrate
Immunologic Factors
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on December 02, 2016