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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Hypercholesterolemia

Dyslipidemia

Treatments

Biological: 0.5 mg/kg

Biological: 4 mg/kg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01163851

B1481003

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.