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Completed

NCT Number: NCT01443650

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

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)

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

alirocumab SAR236553 (REGN727)

Drug

Pharmaceutical form:solution Route of administration: subcutaneous

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 30, 2011
Registry last updated
Jun 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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