Status:
COMPLETED
Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 pat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01161082
Start Date
June 1 2010
End Date
May 1 2011
Last Update
January 27 2015
Active Locations (2)
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1
Site 1
Cincinnati, Ohio, United States
2
Site 2
Knoxville, Tennessee, United States