Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin

Completed · Phase 1

Conditions studied: Hypercholesterolemia, Dyslipidemia

In brief

The primary objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of a single dose of PF-04950615 (RN316) in volunteers on stable doses of atorvastatin. PF-04950615 (RN316) is an investigational drug that is currently being studies as a cholesterol lowering therapy.

Key facts

Study ID

NCT01163851

Run by

Pfizer

People needed

25

Starts

2010-07-01

Expected to finish

2011-04-01

Last updated by the study team

2018-03-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• On stable doses of atorvastatin (40 mg daily) for 45 days prior to Day 1.
• BMI 18.5 to 40 kg/m2 inclusive, and body weight equal or lower than 150 kg.

You may not qualify if…

• History of a cardiovascular event (e.g., MI ) during the past year.
• Poorly controlled Type 1 or Type 2 Diabetes mellitus (definition: uncontrolled diabetes is defined as HBIAc >9%).
• Poorly controlled hypertension (uncontrolled hypertension is defined as a systolic blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm Hg, even with treatment). Subjects who have hypertension and are controlled on stable dosages of anti-hypertensive medications can be included.

Where it is running

• Premier Research Group, Limited — Peoria, Arizona, United States
• Dedicated Phase 1, Inc. — Phoenix, Arizona, United States
• Premier Research Group Limited — Phoenix, Arizona, United States
• Vince and Associates Clinical Research — Overland Park, Kansas, United States
• Vince and Associates Clinical Research — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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