Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects

Hypercholesterolemia Clinical Trial

Official title:

A Randomized Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics After Different Single-Dose Subcutaneous Treatments of SAR236553/REGN727 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443650
• Other study ID #: PKD12275
• Secondary ID: U1111-1120-0670
• Status: Completed
• Phase: Phase 1
• First received: September 21, 2011
• Last updated: June 27, 2013
• Start date: July 2011
• Est. completion date: November 2011

Study information

• Verified date: February 2012
• 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:

Injection Site Tolerability

Secondary Objectives:

• To assess the safety profile of alirocumab SAR236553 (REGN727)

• To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553 (REGN727)

Description:

Total duration for each subject (not including screening) will be approximately 85 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

• Serum LDL-C levels >100 mg/dL.

Exclusion criteria:

• Subjects indicated for the use of statins according to criteria in Adult Treatment Program (ATP) III Guidelines, as updated in 2004.

• Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening. Subjects must be willing to maintain a consistent diet for the duration of the study.

• Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening, including but not limited to statins, cholesterol absorption inhibitors, fibrates, niacin, bile acid resins, or red yeast rice.

• Fasting serum triglycerides >200 mg/dL measured after an 8-12 hour fast.

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: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• alirocumab SAR236553 (REGN727)
Pharmaceutical form:solution Route of administration: subcutaneous

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain using Present Pain Intensity (PPI) verbal questionnaire and Visual Analog Scale (VAS)		15 days	Yes
Primary	Erythema at injection site by measuring diameter and qualitative assessment		15 days	Yes
Primary	Edema at injection site by measuring diameter and qualitative assessment		15 days	Yes
Secondary	Assessment of PK parameter - time to maximum concentration (tmax)		Up to 85 days	No
Secondary	Pharmacodynamics: Change in LDL-C from baseline		Up to 85 days	No
Secondary	Number of participants with Adverse Events		Up to 85 days	Yes
Secondary	Assessment of PK parameter - maximum concentration (Cmax)		Up to 85 days	No
Secondary	Assessment of PK parameter - area under curve (AUC)		Up to 85 days	No
Secondary	Assessment of PK parameter - area under curve versus time curve (AUC0-D29)		Zero to Day 29	No
Secondary	Assessment of PK parameter - plasma concentration on Day 29 (C D29)		Day 29	No
Secondary	Assessment of PK parameter - terminal elimination half-life (t1/2z)		Up to 85 days	No