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Trial record 5 of 5 for:    PF-06410293

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

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

Condition or disease Intervention/treatment Phase
Healthy Subjects Biological: PF-06410293 Biological: Adalimumab-US Biological: Adalimumab-EU Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 362 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : September 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: PF-06410293 Biological: PF-06410293
PF-06410293 will be administered as a single 40 mg, subcutaneous dose
Other Name: Adalimumab-Pfizer

Active Comparator: Adalimumab-US Biological: Adalimumab-US
Adalimumab-US will be administered as a single 40 mg, subcutaneous dose

Active Comparator: Adalimumab-EU
Adalimumab-EU 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




Primary Outcome Measures :
  1. maximal serum concentration (Cmax) [ Time Frame: Day 1 - Day 50 ]
    maximal serum concentration (Cmax)

  2. 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)

  3. 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)

  4. AUC extrapolated to infinity (AUC0inf) [ Time Frame: Day 1 - Day 50 ]
    AUC extrapolated to infinity (AUC0inf)


Secondary Outcome Measures :
  1. 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

  2. Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb) [ Time Frame: Day 1- Day 71 ]
    Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)

  3. 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

  4. 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

  5. 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

  6. 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

  7. time to reach the maximum concentration (Tmax) [ Time Frame: Day 1 - Day 50 ]
    time to reach the maximum concentration (Tmax)

  8. Apparent clearance (CL/F) [ Time Frame: Day 1 - Day 50 ]
    Apparent clearance (CL/F)

  9. Apparent volume of distribution (Vz/F) [ Time Frame: Day 1 - Day 50 ]
    Apparent volume of distribution (Vz/F)

  10. Terminal half-life (T1/2) [ Time Frame: Day 1 - Day 50 ]
    Terminal half-life (T1/2)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237729


Locations
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United States, Florida
De La Pedraja Radiology Associates
Coral Gables, Florida, United States, 33134
SeaView Jacksonville
Jacksonville, Florida, United States, 32256
SeaView Research, Inc.
Miami, Florida, United States, 33126
SeaView Reseach Screening Office
Miami, Florida, United States, 33134
SeaView Research, Inc. (Screening Office)
Miami, Florida, United States, 33134
United States, Kansas
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, United States, 66211
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, United States, 66212
United States, Minnesota
Prism Research, LLC
Saint Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02237729    
Other Study ID Numbers: B5381007
REFLECTIONS B538-07
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015
Keywords provided by Pfizer:
healthy subjects
immunology
PK
Phase 1
bioequivalence
biosimilarity
adalimumab
single dose.
Additional relevant MeSH terms:
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Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents