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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Hypercholesterolemia

Treatments

Biological: Bococizumab (PF-04950615; RN316)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02043301

B1481024

Details and patient eligibility

About

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

Enrollment

75 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.