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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)

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
SeaView Research, Inc.
Miami, Florida, 33126 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neutropenia (Low White Blood Cell Count)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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 neutropenia (defined as absolute neutrophil count [ANC] (defined as platelet count of

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

NCT02766634
Pfizer
Completed
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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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)
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

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®.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Neutropenia (Low White Blood Cell Count)
  • 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
  • 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®
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2016
June 2016   (Final data collection date for primary outcome measure)

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/?L), 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02766634
ZIN-FIL-1501
C1121003 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Hospira, now a wholly owned subsidiary of Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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