Study of the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Alirocumab SAR236553 (REGN727)

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01448304
First received: October 5, 2011
Last updated: June 27, 2013
Last verified: February 2012
  Purpose

Primary Objective:

Injection Site Tolerability

Secondary Objective:

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

Condition Intervention Phase
Hypercholesterolemia
Drug: alirocumab SAR236553 (REGN727)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Pain using present pain intensity (PPI) verbal questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Erythema at injection site by measuring diameter and qualitative assessment [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Edema at injection site by measuring diameter and qualitative assessment [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of PK parameter - time to maximum concentration (tmax) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - maximum concentration (Cmax) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - area under curve (AUC) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - cluster of differentiation (CD) biomarker (CD29) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - terminal elimination half-life (t1/2z) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Change in LDL-C from baseline [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Number of participants with Adverse Events [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alirocumab SAR236553 (REGN727) - Dose A
A single subcutaneous injection of Dose A
Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution Route of administration: Subcutaneous
Experimental: alirocumab SAR236553 (REGN727) - Dose B
A single subcutaneous injection of Dose B
Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution Route of administration: Subcutaneous

Detailed Description:

The total duration of study for each subject is up to 15 weeks including a screening period up to 3 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Serum LDL-C levels>100 mg/dL at screening visit.
  • Male or female subject, between 18 and 65 years inclusive.
  • Body weight between 50.0 and 95.0 kg inclusive if male, between 40.0 kg and 85.0 kg inclusive if female, body mass index (BMI) between 18.0 and 30.0 kg/m² inclusive.
  • Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
  • Normal vital signs after 10 minutes resting in supine position.
  • Normal standard 12-lead ECG after 10 minutes resting in supine position.
  • Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects.
  • If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.

Exclusion Criteria:

  • Subjects indicated for the use of statins according to criteria in National Cholesterol Education Program adult treatment panel III Guidelines, as updated in 2004 (see Appendix C).
  • Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening (Day -21 to -2). 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 (Day -21 to -2), including but not limited to statins, ezetimibe, fibrates, niacin, or omega-3 fatty acids, bile acid resins.
  • Fasting serum triglycerides >200 mg/dL measured after an 8 to 12 hour fast.
  • History of a hypersensitivity reaction to doxycycline or similar compound.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448304

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01448304     History of Changes
Other Study ID Numbers: PKD12011, U1111-1119-3056
Study First Received: October 5, 2011
Last Updated: June 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 16, 2014