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A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)

Last updated on November 8, 2019

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Study Location
Pfizer Investigational Site
Overland Park, Kansas, 66212 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy female subjects of non-childbearing potential and healthy male subjects
(healthy is defined as no clinically relevant abnormalities identified by a detailed
medical history, full physical examination, including blood pressure and pulse rate
measurement, 12-lead ECG and clinical laboratory tests).

- Body Mass Index (BMI) of 17.5 to 32.0 kg/m2; and a total body weight >50kg (110 lbs).

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

- Evidence or history of clinically significant infectious, hematological, renal,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,
neurologic, autoimmune, or allergic disease (including drug allergies, but excluding
untreated, asymptomatic, seasonal allergies at time of dosing).

- Previous exposure to a monoclonal antibody, or current use of other biologics.

- History of hypersensitivity reaction to inactive components of the study drugs or any
murine proteins or anaphylactic reactions to therapeutic drugs.

- History of tuberculosis (TB) or a positive latent TB test at Screening.

NCT01844804
Pfizer
Completed
A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)

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Descriptive Information
Brief Title  ICMJE A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)
Official Title  ICMJE Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study of PF-06438179 and Infliximab Sourced From US and EU Administered to Healthy Volunteers
Brief SummaryIn this study, healthy volunteers will receive a single intravenous dose of either PF-06438179 or infliximab (United States) or infliximab (European Union). During the course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06438179 and the licensed infliximab products. Safety, tolerability, and immunologic response will also be evaluated throughout.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: PF-06438179
    Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
    Other Name: Infliximab-Pfizer
  • Biological: Remicade
    Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
    Other Name: Infliximab (European Union)
  • Biological: Remicade
    Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
    Other Name: Infliximab (United States)
Study Arms  ICMJE
  • Experimental: A = PF-06438179
    Intervention: Biological: PF-06438179
  • Active Comparator: B = Infliximab-EU
    Intervention: Biological: Remicade
  • Active Comparator: C = Infliximab-US
    Intervention: Biological: Remicade
Publications *Palaparthy R, Udata C, Hua SY, Yin D, Cai CH, Salts S, Rehman MI, McClellan J, Meng X. A randomized study comparing the pharmacokinetics of the potential biosimilar PF-06438179/GP1111 with Remicade® (infliximab) in healthy subjects (REFLECTIONS B537-01). Expert Rev Clin Immunol. 2018 Apr;14(4):329-336. doi: 10.1080/1744666X.2018.1446829. Epub 2018 Mar 12.


*   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: January 6, 2014)
146
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2013)
129
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion DateNovember 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy female subjects of non-childbearing potential and healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 32.0 kg/m2; and a total body weight >50kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Previous exposure to a monoclonal antibody, or current use of other biologics.
  • History of hypersensitivity reaction to inactive components of the study drugs or any murine proteins or anaphylactic reactions to therapeutic drugs.
  • History of tuberculosis (TB) or a positive latent TB test at Screening.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (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 NCT01844804
Other Study ID Numbers  ICMJE B5371001
REFLECTIONS B537-01
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2014

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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