Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-29 @ 8:17 PM
Study NCT ID:
NCT01723735
Status:
COMPLETED
Last Update Posted:
2016-09-28
First Post:
2012-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects
Sponsor:
Sanofi
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: