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

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ClinicalTrials.gov Identifier: NCT01443650
Recruitment Status : Completed
First Posted : September 30, 2011
Last Update Posted : June 28, 2013
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Study Description
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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)

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: alirocumab SAR236553 (REGN727) Phase 1

Detailed Description:
Total duration for each subject (not including screening) will be approximately 85 days.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Alirocumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: alirocumab SAR236553 (REGN727) (Formulation A x 1)
A single subcutaneous injection of Formulation A
 Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:solution Route of administration: subcutaneous
Experimental: alirocumab SAR236553 (REGN727) (Formulation B x 1)
A single subcutaneous injection of Formulation B
 Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:solution Route of administration: subcutaneous
Experimental: alirocumab SAR236553 (REGN727) (Formulation A x 2)
2 single subcutaneous injections of Formulation A
 Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:solution Route of administration: subcutaneous


Outcome Measures
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Primary Outcome Measures :
  1. Pain using Present Pain Intensity (PPI) verbal questionnaire and Visual Analog Scale (VAS) [ Time Frame: 15 days ]
  2. Erythema at injection site by measuring diameter and qualitative assessment [ Time Frame: 15 days ]
  3. Edema at injection site by measuring diameter and qualitative assessment [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. Assessment of PK parameter - time to maximum concentration (tmax) [ Time Frame: Up to 85 days ]
  2. Pharmacodynamics: Change in LDL-C from baseline [ Time Frame: Up to 85 days ]
  3. Number of participants with Adverse Events [ Time Frame: Up to 85 days ]
  4. Assessment of PK parameter - maximum concentration (Cmax) [ Time Frame: Up to 85 days ]
  5. Assessment of PK parameter - area under curve (AUC) [ Time Frame: Up to 85 days ]
  6. Assessment of PK parameter - area under curve versus time curve (AUC0-D29) [ Time Frame: Zero to Day 29 ]
  7. Assessment of PK parameter - plasma concentration on Day 29 (C D29) [ Time Frame: Day 29 ]
  8. Assessment of PK parameter - terminal elimination half-life (t1/2z) [ Time Frame: Up to 85 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443650


Locations
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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01443650    
Other Study ID Numbers: PKD12275
U1111-1120-0670 ( Other Identifier: UTN )
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: February 2012
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases