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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 May 11, 2018

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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Pharmacokinetics And Relative Bioavailability Of Bococizumab (PF-04950615; RN316) When Administered To The Abdomen, Thigh Or Upper Arm
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Hypercholesterolemia
  • Biological: Bococizumab (PF-04950615; RN316)
    Single 150 mg PF-04950615 dose administered SC to the abdomen
  • Biological: Bococizumab (PF-04950615; RN316)
    Single 150 mg PF-04950615 dose administered SC to the upper arm
  • Biological: Bococizumab (PF-04950615; RN316)
    Single 150 mg PF-04950615 dose administered SC to the thigh
  • Active Comparator: Single 150 mg PF-04950615 dose administered to the abdomen
    Intervention: Biological: Bococizumab (PF-04950615; RN316)
  • Experimental: Single 150 mg PF-04950615 dose administered to the upper arm
    Intervention: Biological: Bococizumab (PF-04950615; RN316)
  • Experimental: Single 150 mg PF-04950615 dose administered to the thigh
    Intervention: Biological: Bococizumab (PF-04950615; RN316)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
November 2014
November 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02043301
B1481024
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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