A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia
NCT ID: NCT01435382
Last Updated: 2018-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
49 participants
INTERVENTIONAL
2011-10-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Group A
PF-04950615 (RN316)
Dose A - single-dose intravenous infusion
Group B
PF-04950615 (RN316)
Dose B - single-dose subcutaneous injection
Group C
PF-04950615 (RN316)
Dose C - single-dose subcutaneous injection
Group D
PF-04950615 (RN316)
Dose D - single-dose subcutaneous injection
Interventions
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PF-04950615 (RN316)
Dose A - single-dose intravenous infusion
PF-04950615 (RN316)
Dose B - single-dose subcutaneous injection
PF-04950615 (RN316)
Dose C - single-dose subcutaneous injection
PF-04950615 (RN316)
Dose D - single-dose subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* Total body weight greater than or equal to 50 kg (110 lbs) and less than or equal to 150 kg (330 lbs)
Exclusion Criteria
* Poorly controlled type 1 or type 2 diabetes.
* History of a cardiovascular or cerebrovascular event or related procedure during the past year.
* Poorly controlled hypertension.
18 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Profil Institute for Clinical Research, Inc.
Chula Vista, California, United States
Elite Research Institute
Miami, Florida, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
PAREXEL International - Baltimore Early Phase Clinical Unit
Baltimore, Maryland, United States
Jasper Clinic, Inc.
Kalamazoo, Michigan, United States
Prism Research
Saint Paul, Minnesota, United States
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States
Countries
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References
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Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
Udata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development. J Clin Pharmacol. 2017 Jul;57(7):855-864. doi: 10.1002/jcph.867. Epub 2017 Feb 9.
Related Links
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Other Identifiers
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B1481006
Identifier Type: -
Identifier Source: org_study_id
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