Clinical Trial: A Research Study To Test How Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given By Subcutaneous Injection (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Open-Label, Single-Dose, Crossover Study Evaluating The Pharmacokinetics And Pharmacodynamics Of Filgrastim Hospira Compared To U.S.-Approved Neupogen® (Amgen) Following Subcutaneous

Brief Summary:

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®.


Detailed Summary:

This is a randomized, open-label, single-dose, two-way crossover study evaluating the PK and PD equivalence following SC administration of test and reference product in healthy volunteers. The study will be conducted at a single Phase 1 unit.

After meeting the selection criteria, subjects will be randomly assigned to 1 of the 2 treatment sequences:

  • Filgrastim Hospira (US) followed by US-approved Neupogen®
  • US-approved Neupogen® followed by Filgrastim Hospira (US)

Subjects will receive one of the drugs in the first Period and the other drug in the other Period.


Sponsor: Pfizer

Current Primary Outcome:

  • Area under the serum filgrastim concentration versus time curve from zero to infinity (AUC0-∞) [ Time Frame: 1 hour prior to dose administration and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours after dose administration ]
  • Maximum serum filgrastim concentration (Cmax) [ Time Frame: 1 hour prior to dose administration and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours after dose administration ]
  • Area under the effect curve for Absolute Neutrophil Count (ANC) (AUEC ANC) [ Time Frame: 1 hour prior to dose administration and 0.5, 1, 2, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dose administration ]
  • Maximum observed ANC ( ANC max) [ Time Frame: 1 hour prior to dose administration and 0.5, 1, 2, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dose administration ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to maximum serum filgrastim concentration (Tmax) [ Time Frame: 1 hour prior to dose administration and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours after dose administration ]
  • Elimination half-life (t ½) [ Time Frame: 1 hour prior to dose administration and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours after dose administration ]
  • Area under the serum filgrastim concentration versus time curve from time zero to the time of the last measurable concentration versus time curve from time zero to the time of the last measurable concentration (AUC0-t) [ Time Frame: 1 hour prior to dose administration and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours after dose administration ]
  • Clearance (CL) [ Time Frame: 1 hour prior to dose administration and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours after dose administration ]
  • Time to maximum ANC (Tmax[ANC]) [ Time Frame: 1 hour prior to dose administration and 0.5, 1, 2, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dose administration ]
  • Volume of distribution (Vd) [ Time Frame: 1 hour prior to dose administration and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours after dose administration ]


Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: May 6, 2016
Date Started: December 2015
Date Completion:
Last Updated: May 6, 2016
Last Verified: May 2016