A Randomized Open-label, Multiple-dose, Crossover Study Evaluatig The Pharmacodynamics And Pharmacokinetics Of Filgrastim Hospira Compared To Us-approved Neupogen (Registered) Following Subcutaneous Administration To Healthy Volunteers
Sponsor study identifier
Secondary identifiers
OTHER · Alias Study Number
interventional
60
1 country
2
Study Start
March 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds of white blood cells (WBC) known as neutrophils. This type of white cell is important in fighting infections. A low neutrophil count is known as neutropenia. Both drugs work by increasing the number of neutrophils that are produced in the body. This is important for patients who have low neutrophils due to chemotherapy, other treatments such as bone marrow transplant or certain other conditions with symptoms/problems related to low neutrophil counts. The main aim of the study is to test how Filgrastim Hospira works in the body compared to Neupogen®.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2016
Date type not reportedThis date has not been verified as actual or estimated.
May 6, 2016
Actual (reported)May 10, 2016
Actual (reported)June 2016
Actual (reported)June 2016
Actual (reported)The Area under the effect curve for CD34+ (AUECCD34+)
prior to study drug administration on Days 1, 2, 3, 4, 5, and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period
Maximum observed value for CD34+ (CD34+max)
prior to study drug administration on Days 1, 2, 3, 4, 5, and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period
Area under the serum filgrastim concentration versus time curve from time zero to 24 hours (AUC0-24)
prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period
Maximum serum filgrastim concentration (Cmax) following study drug administration on Day 5
prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period
Time to maximum CD34+ count (Tmax[CD34+])
prior to study drug administration on Days 1, 2, 3, 4, 5, and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period
The concentration prior to dose on Day 5 (Ctrough)
prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period.
Time to maximum serum filgrastim concentration (Tmax)
prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period.
Elimination half-life (t1/2) from serum filgrastim concentrations following dose administration on Day 5
prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period.
5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection once a day for 5 days
5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection once a day for 5 days
SeaView Research, Inc.
Miami, Florida, 33126, United States
SeaView Research, Inc.
Miami, Florida, 33134, United States
Yao HM, Ottery FD, Borema T, Harris S, Levy J, May TB, Moosavi S, Zhang J, Summers M. PF-06881893 (Nivestym), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen(R)): Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers. BioDrugs. 2019 Apr;33(2):207-220. doi: 10.1007/s40259-019-00343-8.
Pfizer CT.gov Call Center
Pfizer
60 participants (actual enrollment reported by the registry).
First Submitted
May 6, 2016
First Posted
May 10, 2016
Study Start
March 2016
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
July 21, 2016
Record last verified: 2016-07
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Source: ClinicalTrials.gov.
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