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

Completed · Phase 1

Conditions studied: Hypercholesterolemia

In brief

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

Key facts

Study ID

NCT02043301

Run by

Pfizer

People needed

75

Starts

2014-04-01

Expected to finish

2014-11-01

Last updated by the study team

2019-05-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Miami Research Associates — South Miami, Florida, United States
• MRA Clinical Research, LLC — South Miami, Florida, United States
• Vince & Associates Clinical Research, Inc. — Overland Park, Kansas, United States
• Vince & Associates Clinical Research, Inc. — Overland Park, Kansas, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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