Clinical trial NCT01443650: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2011-09-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain using Present Pain Intensity (PPI) verbal questionnaire and Visual Analog Scale (VAS)
timeFrame: 15 days
measure: Erythema at injection site by measuring diameter and qualitative assessment
timeFrame: 15 days
measure: Edema at injection site by measuring diameter and qualitative assessment
timeFrame: 15 days
Secondary outcomes:
measure: Assessment of PK parameter - time to maximum concentration (tmax)
timeFrame: Up to 85 days
measure: Pharmacodynamics: Change in LDL-C from baseline
timeFrame: Up to 85 days
measure: Number of participants with Adverse Events
timeFrame: Up to 85 days
measure: Assessment of PK parameter - maximum concentration (Cmax)
timeFrame: Up to 85 days
measure: Assessment of PK parameter - area under curve (AUC)
timeFrame: Up to 85 days
measure: Assessment of PK parameter - area under curve versus time curve (AUC0-D29)
timeFrame: Zero to Day 29
measure: Assessment of PK parameter - plasma concentration on Day 29 (C D29)
timeFrame: Day 29
measure: Assessment of PK parameter - terminal elimination half-life (t1/2z)
timeFrame: Up to 85 days
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: