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

Last updated on June 4, 2019

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Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT02043301
Pfizer
Completed
Pharmacokinetics And Relative Bioavailability Of Bococizumab (PF-04950615; RN316) When Administered To The Abdomen, Thigh Or Upper Arm

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