Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin

Hypercholesterolemia Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Ascending Single to Multi-Dose Study of Safety, Tolerability, and Bioeffect of Subcutaneously Administered REGN727 in Patients With and Without Concomitant Atorvastatin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01161082
• Other study ID #: R727-CL-1001
• Status: Completed
• Phase: Phase 1
• First received: July 9, 2010
• Last updated: January 24, 2015
• Start date: June 2010
• Est. completion date: May 2011

Study information

• Verified date: November 2011
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will test the safety, tolerability, and bioeffects (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in hyperlipidemic patients with or without atorvastatin therapy. The study drug and placebo will be administered by subcutaneous injection at the clinic. There will be a total of 2 or 3 study drug injections over 16 clinic visits, which will include 3 overnight stays(study duration 148 days, not including the screening period). Patients on atorvastatin will take their daily dose in the morning for the duration of the study. Patients will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria

• Men and women with elevated cholesterol on stable doses of atorvastatin 10-40mg/day regimen

• Body mass index between 18.0 and 35.0 kg/m2, inclusive

• For women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on day -2 or day -1

• For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant)during the full duration of the study

• Willing, committed and able to return for all the clinic visits and complete all study-related procedures

• Able to read, and able to sign the informed consent form

Exclusion Criteria:

• History of MI, ACS, Angina, Stroke, peripheral vascular disease, or cardiac revascularization

• Pregnant or breast-feeding women

• Blood donation of any volume within 1 month prior to administration of study drug

• Congestive heart failure

• Consumption of greater than 1 quart of grapefruit juice per day

• Previous exposure to any therapeutic or investigational biological agent within 30 days of screening

• History of alcohol or drug abuse within one year to the screening visit

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• REGN727(SAR236553)
subcutaneous

Locations

Country	Name	City	State
United States	Site 1	Cincinnati	Ohio
United States	Site 2	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin.		visit 4 (day 1) to visit 16 (day 148)	No
Secondary	To assess the pharmacodynamic effect of REGN727 added to atorvastatin on lipids		Visit 4 (Day 1) to Visit 16 (Day 148)	No
Secondary	To assess the pharmacodynamic effect of monotherapy REGN727 in hyperlipidemic patients		Visit 4 (Day 1) to Visit 16 (Day 148)	No
Secondary	To assess the pharmacokinetics of REGN727 in hyperlipidemic patients with or without atorvastatin		Visit 4 (Day 1) to Visit 16 (Day 148)	No