A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, High Cholesterol, Endocrine |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/25/2018 |
| Start Date: | October 2011 |
| End Date: | April 2012 |
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.
(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.
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