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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)

Primary Purpose

Neutropenia (Low White Blood Cell Count)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Filgrastim Hospira (US)
U.S.-approved Neupogen®
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neutropenia (Low White Blood Cell Count) focused on measuring filgrastim

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • SeaView Research, Inc.
  • SeaView Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Filgrastim Hospira (US) followed by U.S.-approved Neupogen®

U.S.-approved Neupogen® followed by Filgrastim Hospira (US)

Arm Description

Outcomes

Primary Outcome Measures

The Area under the effect curve for CD34+ (AUECCD34+)
Maximum observed value for CD34+ (CD34+max)
Area under the serum filgrastim concentration versus time curve from time zero to 24 hours (AUC0-24)
Maximum serum filgrastim concentration (Cmax) following study drug administration on Day 5

Secondary Outcome Measures

Time to maximum CD34+ count (Tmax[CD34+])
The concentration prior to dose on Day 5 (Ctrough)
Time to maximum serum filgrastim concentration (Tmax)
Elimination half-life (t1/2) from serum filgrastim concentrations following dose administration on Day 5

Full Information

First Posted
May 6, 2016
Last Updated
July 20, 2016
Sponsor
Pfizer
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02766634
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia (Low White Blood Cell Count)
Keywords
filgrastim

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Filgrastim Hospira (US) followed by U.S.-approved Neupogen®
Arm Type
Experimental
Arm Title
U.S.-approved Neupogen® followed by Filgrastim Hospira (US)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Filgrastim Hospira (US)
Intervention Description
5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection once a day for 5 days
Intervention Type
Biological
Intervention Name(s)
U.S.-approved Neupogen®
Intervention Description
5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection once a day for 5 days
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A subject will be eligible for study participation if all of the following criteria are met at Screening: Provides written informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB) prior to any study related activities Healthy male or female volunteers between 18 and 65 years of age (both inclusive) Body mass index (BMI) between 19 and 30 kg/m2, inclusive, and body weight of not < 50 kg or > 100 kg 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 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 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: 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 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) Clinically significant, as judged by the Investigator, vital sign, chest X-ray, or 12-lead electrocardiogram (ECG) abnormality 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 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 History of splenic rupture (or subject who is asplenic), pulmonary infiltrate or pneumonia, sickle cell disorders, chronic neutropenia, thrombocytopenia, or vasculitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
SeaView Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
SeaView Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30900158
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=ZIN-FIL-1501&StudyName=A+Randomized+Open-label%2C+Multiple-dose%2C+Crossover+Study+Evaluatig+The+Pharmacodynamics+And+Pharmacokinetics+Of+Filgrastim+Hospira+Compared+To+Us-approved+Neupogen+%28registered%29+Following+Subcutaneous+Administration+To+Healthy+Volunteers
Description
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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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