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

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NCT01870986

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
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Contact
1-800-718-1021
[email protected]
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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 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
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.

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Advanced Information
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
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
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