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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Single 150 mg PF-04950615 dose administered to the abdomen

Group Type ACTIVE_COMPARATOR

Bococizumab (PF-04950615; RN316)

Intervention Type BIOLOGICAL

Single 150 mg PF-04950615 dose administered SC to the abdomen

Single 150 mg PF-04950615 dose administered to the upper arm

Group Type EXPERIMENTAL

Bococizumab (PF-04950615; RN316)

Intervention Type BIOLOGICAL

Single 150 mg PF-04950615 dose administered SC to the upper arm

Single 150 mg PF-04950615 dose administered to the thigh

Group Type EXPERIMENTAL

Bococizumab (PF-04950615; RN316)

Intervention Type BIOLOGICAL

Single 150 mg PF-04950615 dose administered SC to the thigh

Interventions

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Bococizumab (PF-04950615; RN316)

Single 150 mg PF-04950615 dose administered SC to the abdomen

Intervention Type BIOLOGICAL

Bococizumab (PF-04950615; RN316)

Single 150 mg PF-04950615 dose administered SC to the upper arm

Intervention Type BIOLOGICAL

Bococizumab (PF-04950615; RN316)

Single 150 mg PF-04950615 dose administered SC to the thigh

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No