A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia

A Phase 1, Open-label, Randomized, Single Dose, Parallel Group Study To Assess The Pharmacokinetics And Pharmacodynamics Of Pf-04950615 Following Subcutaneous And Intravenous Doses In Adult Subjects With Hypercholesterolemia

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.

Inclusion Criteria:

• 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 Criteria:

• 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.