Pharmacokinetics And Relative Bioavailability Of Bococizumab (PF-04950615; RN316) When Administered To The Abdomen, Thigh Or Upper Arm

Status:	Completed
Conditions:	High Cholesterol
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 65
Updated:	10/14/2017
Start Date:	April 2014
End Date:	November 2014

A Phase 1, Open-label, Randomized, Single Dose, Parallel Group Study To Assess Injection Site Relative Bioavailability Of Pf-04950615 Following Subcutaneous Administration In Adult Subjects With Hypercholesterolemia

This study aims to characterize the single dose pharmacokinetics of PF-04950616 following
subcutaneous injection to the abdomen, upper arm or the thigh.

Inclusion Criteria:

- Male and female subjects 18 to 65 years of age.

- Body Mass Index (BMI) ≤ 33 kg/m2, and total body weight of 60 kg to 90 kg (132 lbs to
198 lbs).

- Fasting LDL-C must be > 130 mg/dL (borderline high per NCEP ATP III criteria) at two
qualifying visits: initial screening (Days -28 to -14) and Day -7.

Exclusion Criteria:

- Poorly controlled type 1 or type 2 diabetes mellitus (HbA1c > 9.0%).

- History of a cardiovascular or cerebrovascular event (eg, MI, stroke, TIA) or related
procedure (eg, angioplasty) during the past year.

- Subjects who meet the New York Heart Association (NYHA) criteria for congestive heart
failure (CHF) classes III or IV.

We found this trial at

sites

Clinical Trials of Texas, Inc.

7940 Floyd Curl Dr.
San Antonio, Texas 78229

210-949-0122