Pharmacokinetics And Relative Bioavailability Of Bococizumab (PF-04950615; RN316) When Administered To The Abdomen, Thigh Or Upper Arm
NCT02043301
ABOUT THIS 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.
- 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.
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Descriptive Information | |||||
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Brief Title ICMJE | Pharmacokinetics And Relative Bioavailability Of Bococizumab (PF-04950615; RN316) When Administered To The Abdomen, Thigh Or Upper Arm | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | This study aims to characterize the single dose pharmacokinetics of PF-04950616 following subcutaneous injection to the abdomen, upper arm or the thigh. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science | ||||
Condition ICMJE | Hypercholesterolemia | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Wang EQ, Plotka A, Salageanu J, Sattler C, Yunis C. Pharmacokinetics and pharmacodynamics of bococizumab, a monoclonal antibody to PCSK9, after single subcutaneous injection at three sites [NCT 02043301]. Cardiovasc Ther. 2017 Oct;35(5). doi: 10.1111/1755-5922.12278. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 75 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | November 2014 | ||||
Actual Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02043301 | ||||
Other Study ID Numbers ICMJE | B1481024 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | February 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |