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

Completed · Phase 1

Conditions studied: Hypercholesterolemia, Dyslipidemias, Hyperlipidemias, Lipid Metabolism Disorders, Metabolic Diseases

In brief

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.

Key facts

Study ID

NCT01435382

Run by

Pfizer

People needed

49

Starts

2011-10-01

Expected to finish

2012-04-01

Last updated by the study team

2018-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Profil Institute for Clinical Research, Inc. — Chula Vista, California, United States
• Elite Research Institute — Miami, Florida, United States
• Vince and Associates Clinical Research — Overland Park, Kansas, United States
• PAREXEL International - Baltimore Early Phase Clinical Unit — Baltimore, Maryland, United States
• Jasper Clinic, Inc. — Kalamazoo, Michigan, United States
• Prism Research — Saint Paul, Minnesota, United States
• Medpace Clinical Pharmacology Unit — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.