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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

alirocumab SAR236553 (REGN727)

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

alirocumab SAR236553 (REGN727) (Formulation A x 1)

alirocumab SAR236553 (REGN727) (Formulation B x 1)

alirocumab SAR236553 (REGN727) (Formulation A x 2)

Arm Description

A single subcutaneous injection of Formulation A

A single subcutaneous injection of Formulation B

2 single subcutaneous injections of Formulation A

Outcomes

Primary Outcome Measures

Pain using Present Pain Intensity (PPI) verbal questionnaire and Visual Analog Scale (VAS)

Erythema at injection site by measuring diameter and qualitative assessment

Edema at injection site by measuring diameter and qualitative assessment

Secondary Outcome Measures

Assessment of PK parameter - time to maximum concentration (tmax)

Pharmacodynamics: Change in LDL-C from baseline

Number of participants with Adverse Events

Assessment of PK parameter - maximum concentration (Cmax)

Assessment of PK parameter - area under curve (AUC)

Assessment of PK parameter - area under curve versus time curve (AUC0-D29)

Assessment of PK parameter - plasma concentration on Day 29 (C D29)

Assessment of PK parameter - terminal elimination half-life (t1/2z)

Full Information

NCT ID

NCT01443650

First Posted

September 21, 2011

Last Updated

June 27, 2013

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01443650

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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)

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

alirocumab SAR236553 (REGN727) (Formulation A x 1)

Arm Type

Experimental

Arm Description

A single subcutaneous injection of Formulation A

Arm Title

alirocumab SAR236553 (REGN727) (Formulation B x 1)

Arm Type

Experimental

Arm Description

A single subcutaneous injection of Formulation B

Arm Title

alirocumab SAR236553 (REGN727) (Formulation A x 2)

Arm Type

Experimental

Arm Description

2 single subcutaneous injections of Formulation A

Intervention Type

Drug

Intervention Name(s)

alirocumab SAR236553 (REGN727)

Intervention Description

Pharmaceutical form:solution Route of administration: subcutaneous

Primary Outcome Measure Information:

Title

Pain using Present Pain Intensity (PPI) verbal questionnaire and Visual Analog Scale (VAS)

Time Frame

15 days

Title

Erythema at injection site by measuring diameter and qualitative assessment

Time Frame

15 days

Title

Edema at injection site by measuring diameter and qualitative assessment

Time Frame

15 days

Secondary Outcome Measure Information:

Title

Assessment of PK parameter - time to maximum concentration (tmax)

Time Frame

Up to 85 days

Title

Pharmacodynamics: Change in LDL-C from baseline

Time Frame

Up to 85 days

Title

Number of participants with Adverse Events

Time Frame

Up to 85 days

Title

Assessment of PK parameter - maximum concentration (Cmax)

Time Frame

Up to 85 days

Title

Assessment of PK parameter - area under curve (AUC)

Time Frame

Up to 85 days

Title

Assessment of PK parameter - area under curve versus time curve (AUC0-D29)

Time Frame

Zero to Day 29

Title

Assessment of PK parameter - plasma concentration on Day 29 (C D29)

Time Frame

Day 29

Title

Assessment of PK parameter - terminal elimination half-life (t1/2z)

Time Frame

Up to 85 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Bridgewater

State/Province

New Jersey

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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