Clinical Trial: A Research Study To Test How Multiple Doses Of Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given by Subcutaneous Injection (SC) (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, Multiple-dose, Crossover Study Evaluatig The Pharmacodynamics And Pharmacokinetics Of Filgrastim Hospira Compared To Us-approved Neupogen (Registered) Following Subcutaneous A

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, multiple-dose, crossover study evaluating the pharmacodynamics and Pharmacokinetics equivalence following SC administration of test and reference product in healthy volunteers. The study will be conducted at a single Phase 1 unit. There will be 30 healthy subjects in each of the two sequences.

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

  • Filgrastim Hospira (US) in Period 1 followed by US-approved Neupogen® in Period 2.
  • US-approved Neupogen® in Period 1 followed by Filgrastim Hospira (US) in Period 2.

Subjects will receive one of each of the drugs once a day for 5 days in each of the treatment sequences.


Sponsor: Pfizer

Current Primary Outcome:

  • The Area under the effect curve for CD34+ (AUECCD34+) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to maximum CD34+ count (Tmax[CD34+]) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period. ]


Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: May 6, 2016
Date Started: March 2016
Date Completion:
Last Updated: July 20, 2016
Last Verified: July 2016