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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)

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ClinicalTrials.gov Identifier: NCT02766634
Recruitment Status : Completed
First Posted : May 10, 2016
Last Update Posted : July 21, 2016
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 6, 2016
First Posted Date  ICMJE May 10, 2016
Last Update Posted Date July 21, 2016
Study Start Date  ICMJE March 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2016)
  • 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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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 Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Neutropenia (Low White Blood Cell Count)
Intervention  ICMJE
  • Biological: Filgrastim Hospira (US)
    5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection once a day for 5 days
  • Biological: U.S.-approved Neupogen®
    5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection once a day for 5 days
Study Arms  ICMJE
  • Experimental: Filgrastim Hospira (US) followed by U.S.-approved Neupogen®
    Interventions:
    • Biological: Filgrastim Hospira (US)
    • Biological: U.S.-approved Neupogen®
  • Experimental: U.S.-approved Neupogen® followed by Filgrastim Hospira (US)
    Interventions:
    • Biological: Filgrastim Hospira (US)
    • Biological: U.S.-approved Neupogen®
Publications * 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(®)): 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

A subject will be eligible for study participation if all of the following criteria are met at Screening:

  1. Provides written informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB) prior to any study related activities
  2. Healthy male or female volunteers between 18 and 65 years of age (both inclusive)
  3. Body mass index (BMI) between 19 and 30 kg/m2, inclusive, and body weight of not < 50 kg or > 100 kg
  4. Non smoker (defined as a subject who has not smoked and has not used nicotine containing products for at least 3 months prior to study drug administration and has a negative urine screen for cotinine) at Screening
  5. Female subjects of childbearing potential and male subjects and their partners of childbearing potential, agree to pregnancy prevention throughout the duration of the study (through the Final Visit). Subjects and their partners must agree to use of an effective method of contraception, to avoid impregnation of females throughout the course of the study. Subjects using oral contraceptives must be on a stable regimen for at least 3 months prior to Screening. While the best way to avoid pregnancy is to abstain from sexual activity, adequate forms of contraception to be used include oral contraception, depot contraception, intrauterine device (IUD), and barrier contraceptive methods, such as condoms and barrier creams/contraceptive jellies, and spermicidals. Subjects and their partners who can become pregnant must use contraception while on study drug from admission to the Final Visit. Male subjects must also refrain from donating sperm from admission to the Final Visit
  6. Agrees to abstain from alcohol consumption throughout duration of the study and has a negative urine for alcohol at Screening

Exclusion Criteria:

A subject will NOT be eligible for study participation if any of the following criteria are met at Screening:

  1. Any active systemic or immunologic disease or condition, including but not limited to the following general categories: cardiovascular/pulmonary, hepatorenal, or systemic infection, or lactation
  2. Hematologic laboratory abnormalities including leukocytosis (defined as total leukocytes > 11,000/µL), leukopenia (defined as total leukocytes < 4000/μL), or neutropenia (defined as absolute neutrophil count [ANC] < 1500/µL) or thrombocytopenia (defined as platelet count of < 150/µL)
  3. Clinically significant, as judged by the Investigator, vital sign, chest X-ray, or 12-lead electrocardiogram (ECG) abnormality
  4. History of biological growth factor exposure, including but not limited to filgrastim and other granulocyte-colony stimulating factors (G-CSFs) in the context of treatment, prophylaxis, peripheral blood stem cell mobilization, or previous investigational study setting
  5. Drug sensitivity, allergic reaction to, or known hypersensitivity/idiosyncratic reaction to Escherichia coli-derived proteins, filgrastim, pegfilgrastim, other granulocyte colony-stimulating factors or any component of the product: Subjects with the rare heredity problem of fructose intolerance are excluded due to the excipient sorbitol
  6. History of splenic rupture (or subject who is asplenic), pulmonary infiltrate or pneumonia, sickle cell disorders, chronic neutropenia, thrombocytopenia, or vasculitis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02766634
Other Study ID Numbers  ICMJE ZIN-FIL-1501
C1121003 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP