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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Ezetimibe; Fenofibrate

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.