NCT01435382

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypercholesterolemia
• Dyslipidemias
• Hyperlipidemias
• Lipid Metabolism Disorders
• Metabolic Diseases

Interventions

Type	Name	Description
BIOLOGICAL	PF-04950615 (RN316)	Dose A - single-dose intravenous infusion
BIOLOGICAL	PF-04950615 (RN316)	Dose B - single-dose subcutaneous injection
BIOLOGICAL	PF-04950615 (RN316)	Dose C - single-dose subcutaneous injection
BIOLOGICAL	PF-04950615 (RN316)	Dose D - single-dose subcutaneous injection

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-02-01
• Completion: 2012-04-01
• First posted: 2011-09-16
• Last updated: 2018-07-23
• Results posted: 2018-07-23

Locations

7 sites across 1 country: United States