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

NCT01723735 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2016-09-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Alirocumab

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

Ezetimibe

Pharmaceutical form: overencapsulated tablet Route of administration: oral

DRUG

Ezetimibe Placebo

Pharmaceutical form: capsule Route of administration: oral

DRUG

Fenofibrate

Pharmaceutical form: tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01723735 on ClinicalTrials.gov