Status:
COMPLETED
A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia
Lead Sponsor:
Pfizer
Conditions:
Hypercholesterolemia
Dyslipidemias
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This Phase 1 study has been designed to evaluate the absolute bioavailability of PF-04950615 (RN316) in subjects with hypercholesterolemia who are not currently on lipid-lowering therapy.
Eligibility Criteria
Inclusion
- Fasting LDL-C greater than or equal to 130 mg/dL at two qualifying screening visits.
- Total body weight greater than or equal to 50 kg (110 lbs) and less than or equal to 150 kg (330 lbs)
Exclusion
- Lipid-lowering prescription medications, homeopaths, herbal medicines, or nutritional supplements.
- Poorly controlled type 1 or type 2 diabetes.
- History of a cardiovascular or cerebrovascular event or related procedure during the past year.
- Poorly controlled hypertension.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01435382
Start Date
October 1 2011
End Date
April 1 2012
Last Update
July 23 2018
Active Locations (7)
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1
Profil Institute for Clinical Research, Inc.
Chula Vista, California, United States, 91911
2
Elite Research Institute
Miami, Florida, United States, 33169
3
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
4
PAREXEL International - Baltimore Early Phase Clinical Unit
Baltimore, Maryland, United States, 21225