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

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ClinicalTrials.gov Identifier: NCT01844804
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : January 7, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 29, 2013
First Posted Date  ICMJE May 1, 2013
Last Update Posted Date January 7, 2014
Study Start Date  ICMJE May 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2013)
  • Maximum Observed Serum Concentration (Cmax) [ Time Frame: Day 1 - Day 57 ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt) [ Time Frame: Day 1 - Day 57 ]
  • Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf) [ Time Frame: Day 1 - Day 57 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2013)
  • Systemic Clearance (CL) [ Time Frame: Day 1 - Day 57 ]
  • Terminal Disposition Half-Life (t1/2) [ Time Frame: Day 1 - Day 57 ]
  • Volume of Distribution at Steady State (Vss) [ Time Frame: Day 1 - Day 57 ]
  • Incidence of anti-infliximab antibodies (ADA), including neutralizing antibodies (Nab) [ Time Frame: Day 1 - LSLV or Day 85 whichever occurs later ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2013)
  • Systemic Clearance (CL) [ Time Frame: Day 1 - Day 57 ]
  • Terminal Disposition Half-Life (t1/2) [ Time Frame: Day 1 - Day 57 ]
  • Volume of Distribution at Steady State (Vss) [ Time Frame: Day 1 - Day 57 ]
  • Incidence of anti-infliximab antibodies (ADA), including neutralizing antibodies (Nab) [ Time Frame: Day 1 - LSLV or Day 57 whichever occurs later ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Summary In 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 Description Not 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 Date November 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 Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2014

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