Study of the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of SAR236553 (REGN727)
This study has been completed.
Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01448304
First received: October 5, 2011
Last updated: May 22, 2012
Last verified: February 2012
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Purpose
Primary Objective:
Injection Site Tolerability
Secondary Objective:
- To assess the safety profile of SAR236553/REGN727
- To assess the pharmacokinetic-pharmacodynamic relationship pf SAR236553/REGN727
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: 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 differentation (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: SAR236553/REGN727 - Dose A
A single subcutaneous injection of Dose A
|
Drug: SAR236553/REGN727
Pharmaceutical form:Solution Route of administration: Subcutaneous
|
|
Experimental: SAR236553/REGN727 - Dose B
A single subcutaneous injection of Dose B
|
Drug: 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: | May 22, 2012 |
| 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 May 19, 2013