Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects
Phase 1
Completed
- Conditions
- Hypercholesterolemia
- Interventions
- Registration Number
- NCT01723735
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Total duration of the study per subject (excluding screening) is about 22 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alirocumab + Ezetimibe Placebo Ezetimibe Placebo Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe placebo Alirocumab + Ezetimibe Ezetimibe Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe Alirocumab + Fenofibrate Alirocumab Subcutaneous (SC) injections of alirocumab added to oral administration of fenofibrate Alirocumab + Fenofibrate Fenofibrate Subcutaneous (SC) injections of alirocumab added to oral administration of fenofibrate Alirocumab + Ezetimibe Placebo Alirocumab Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe placebo Alirocumab + Ezetimibe Alirocumab Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe
- Primary Outcome Measures
Name Time Method Assessment of the effect of alirocumab on LDL-C Up to 18 weeks
- Secondary Outcome Measures
Name Time Method Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9) Up to 18 weeks Assessment of the pharmacodynamic profile of alirocumab Up to 18 weeks Pharmacokinetics: Assessment of serum concentrations of alirocumab Up to 18 weeks
Trial Locations
- Locations (2)
Investigational Site Number 250001
🇫🇷Rennes, France
Investigational Site Number 250002
🇫🇷Rueil Malmaison, France