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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723735
• Other study ID #: PKD12910
• Secondary ID: U1111-1131-32032
• Status: Completed
• Phase: Phase 1
• First received: November 6, 2012
• Last updated: September 27, 2016
• Start date: November 2012
• Est. completion date: July 2013

Study information

• Verified date: September 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

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

Locations

Country	Name	City	State
France	Investigational Site Number 250001	Rennes
France	Investigational Site Number 250002	Rueil Malmaison

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

France, 

References & Publications (1)

Rey J, Poitiers F, Paehler T, Brunet A, DiCioccio AT, Cannon CP, Surks HK, Pinquier JL, Hanotin C, Sasiela WJ. Relationship Between Low-Density Lipoprotein Cholesterol, Free Proprotein Convertase Subtilisin/Kexin Type 9, and Alirocumab Levels After Differ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the effect of alirocumab on LDL-C		Up to 18 weeks	No
Secondary	Assessment of the pharmacodynamic profile of alirocumab		Up to 18 weeks	No
Secondary	Pharmacokinetics: Assessment of serum concentrations of alirocumab		Up to 18 weeks	No
Secondary	Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9)		Up to 18 weeks	No