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Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01870986
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : February 14, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 3, 2013
First Posted Date  ICMJE June 6, 2013
Last Update Posted Date February 14, 2014
Study Start Date  ICMJE May 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2013)
  • Maximum Observed Serum Concentration (Cmax) [ Time Frame: Day 1 - Day 43 ]
  • Area Under the Curve From Time Zero to Last Time Point with Quantifiable Concentration (AUClast) [ Time Frame: Day 1 - Day 43 ]
  • Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf) [ Time Frame: Day 1 - Day 43 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2013)
  • Incidence of anti-adalimumab antibodies (ADA) and neutralizing antibodies (Nab) [ Time Frame: Day 1 - Day 71 ]
  • Time to Reach Maximum Observed Serum Concentration (Tmax) [ Time Frame: Day 1- Day 43 ]
  • Area under the Concentration-Time Curve (AUC) time Zero to 2 weeks after Dosing [ Time Frame: Day 1- Day 43 ]
  • Systemic Clearance (CL) [ Time Frame: Day 1- Day 43 ]
  • Serum Decay Half-Life (t1/2) [ Time Frame: Day 1- Day 43 ]
    Serum decay half-life is teh time for the serum concentration to decrease by one half
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2013)
  • Incidence of anti-adalimumab antibodies (ADA) and neutralizing antibodies (Nab) [ Time Frame: Day 1 - Day 71 ]
  • Time to Reach Maximum Observed Serum Concentration (Tmax) [ Time Frame: Day 1- Day 43 ]
  • Area under the Concentration-Time Curve (AUC) time Zero to 2 weeks after Dosing [ Time Frame: Day 1- Day 43 ]
  • Systemic Clearance (CL) [ Time Frame: Day 1- Day 43 ]
  • Serum Decay Half-Life (t1/2) [ Time Frame: Day 1- Day 43 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)
Official Title  ICMJE Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-06410293 and Adalimumab Sourced From US And EU Administered To Healthy Subjects
Brief Summary This healthy volunteers study will evaluate 210 subjects who will receive a single sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European Union). This study will involve sampling and pharmacokinetics evaluation of drug levels following administration of PF-06410293 and the licensed adalimumab products.
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-06410293
    40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
    Other Name: adalimumab-Pfizer
  • Biological: Humira (adalimumab-EU)
    40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
    Other Name: adalimumab (European Union)
  • Biological: Humira (adalimumab-US)
    40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
    Other Name: adalimumab (United States)
Study Arms  ICMJE
  • Experimental: A
    PF-06410293
    Intervention: Biological: PF-06410293
  • Active Comparator: B
    Adalimumab-EU
    Intervention: Biological: Humira (adalimumab-EU)
  • Active Comparator: C
    Adalimumab-US
    Intervention: Biological: Humira (adalimumab-US)
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: June 3, 2013)		 210
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and female (non-childbearing potential). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse, ECG, and laboratory testing.

Exclusion Criteria:

  • Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary gastrointestinal, cardiovascular, hepatic psychiatric, neurologic, autoimmune, or allergic disease.
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 Belgium,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01870986
Other Study ID Numbers  ICMJE B5381001
REFLECTIONS B538-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Pfizer
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2014

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