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A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07)) (B538-07)

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ClinicalTrials.gov Identifier: NCT02237729
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 9, 2014
First Posted Date  ICMJE September 11, 2014
Last Update Posted Date April 13, 2015
Study Start Date  ICMJE September 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2014)
  • maximal serum concentration (Cmax) [ Time Frame: Day 1 - Day 50 ]
    maximal serum concentration (Cmax)
  • area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) [ Time Frame: 0-336 hours ]
    area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] [ Time Frame: Day 1 - Day 50 ]
    AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T)
  • AUC extrapolated to infinity (AUC0inf) [ Time Frame: Day 1 - Day 50 ]
    AUC extrapolated to infinity (AUC0inf)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2014)
  • Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters [ Time Frame: Day 1- Day 71 ]
    Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters
  • Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb) [ Time Frame: Day 1- Day 71 ]
    Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)
  • maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US [ Time Frame: Day 1 - Day 50 ]
    maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US
  • area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) for adalimumab EU as compared to adalimumab US [ Time Frame: 0-336 hours ]
    area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk) for adalimumab EU as compared to adalimumab US
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] for adalimumab EU as compared to adalimumab US [ Time Frame: Day 1 - Day 50 ]
    AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T) for adalimumab EU as compared to adalimumab US
  • AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US [ Time Frame: Day 1 - Day 50 ]
    AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US
  • time to reach the maximum concentration (Tmax) [ Time Frame: Day 1 - Day 50 ]
    time to reach the maximum concentration (Tmax)
  • Apparent clearance (CL/F) [ Time Frame: Day 1 - Day 50 ]
    Apparent clearance (CL/F)
  • Apparent volume of distribution (Vz/F) [ Time Frame: Day 1 - Day 50 ]
    Apparent volume of distribution (Vz/F)
  • Terminal half-life (T1/2) [ Time Frame: Day 1 - Day 50 ]
    Terminal half-life (T1/2)
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 Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))
Official Title  ICMJE Phase 1, Double Blind, Randomized, Parallel-group, 3-arm, Single-dose, Comparative Pharmacokinetic Study Of Pf-06410293 and Adalimumab Sourced From Us And Eu Administered To Healthy Male And Female Subjects
Brief Summary This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to healthy male and female volunteers
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 Subjects
Intervention  ICMJE
  • Biological: PF-06410293
    PF-06410293 will be administered as a single 40 mg, subcutaneous dose
    Other Name: Adalimumab-Pfizer
  • Biological: Adalimumab-US
    Adalimumab-US will be administered as a single 40 mg, subcutaneous dose
  • Biological: Adalimumab-EU
    Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose
Study Arms  ICMJE
  • Experimental: PF-06410293
    Intervention: Biological: PF-06410293
  • Active Comparator: Adalimumab-US
    Intervention: Biological: Adalimumab-US
  • Active Comparator: Adalimumab-EU
    Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose
    Intervention: Biological: Adalimumab-EU
Publications * Not Provided

*   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: April 10, 2015)
362
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2014)
285
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and female subjects between the ages of 18 and 45 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.
  • Body Mass Index (BMI) of 19.0 to 30.5 kg/m2; and a total body weight >60 kg (132 lbs).
  • Chest X ray with no evidence of current, active TB or previous (inactive) TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 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 NCT02237729
Other Study ID Numbers  ICMJE B5381007
REFLECTIONS B538-07
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 April 2015

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