Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia
NCT ID: NCT01243151
Last Updated: 2019-01-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
68 participants
INTERVENTIONAL
2011-02-28
2011-10-31
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
TREATMENT
DOUBLE
Study Groups
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A
PF-04950615 (RN316)
Infusion every week
B
PF-04950615 (RN316)
Infusion every week
C
PF-04950615 (RN316)
Infusion every week
D
PF-04950615 (RN316)
Infusion every week
E
PF-04950615 (RN316)
Infusion every week
Interventions
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PF-04950615 (RN316)
Infusion every week
PF-04950615 (RN316)
Infusion every week
PF-04950615 (RN316)
Infusion every week
PF-04950615 (RN316)
Infusion every week
PF-04950615 (RN316)
Infusion every week
Eligibility Criteria
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Inclusion Criteria
* BMI must be between 18.5 and 40 kg/m2
* Japanese volunteers must have 4 Japanese grand parents born in Japan
Exclusion Criteria
* Poorly controlled type 1 or type 2 diabetes mellitus
* Subjects who have taken lipid lowering therapies within the last 3 months of screening.
18 Years
80 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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California Clinical Trials Medical Group
Culver City, California, United States
Glendale Adventist Medical Center
Glendale, California, United States
SeaView Research, Inc.
Miami, Florida, United States
SeaView Research, Inc.
Miami, Florida, United States
Covance Clinical Research Unit, Inc.
Honolulu, Hawaii, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Prism Research
Saint Paul, Minnesota, United States
Healthcare Discoveries, LLC dba ICON Development Solutions
San Antonio, Texas, 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.
Wan H, Gumbiner B, Joh T, Riel T, Udata C, Forgues P, Garzone PD. Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition with Bococizumab on Lipoprotein Particles in Hypercholesterolemic Subjects. Clin Ther. 2017 Nov;39(11):2243-2259.e5. doi: 10.1016/j.clinthera.2017.09.009. Epub 2017 Oct 14.
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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B1481009
Identifier Type: -
Identifier Source: org_study_id
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