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Trial record 69 of 83714 for:    subjects

A Study of PF-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects (B538-05)

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ClinicalTrials.gov Identifier: NCT02572245
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 25, 2015
First Posted Date  ICMJE October 8, 2015
Last Update Posted Date June 6, 2016
Study Start Date  ICMJE January 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
  • Maximum serum concentration (Cmax) [ Time Frame: Day 1 - Day 15 ]
  • Area under the concentration curve (AUC 0-2wk) [ Time Frame: Day 1-Day 15 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02572245 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
  • Injection site tolerability (Subject Assessment - Visual Analog Scale) - Mean Injection site pain over 24 hour period post dose [ Time Frame: Hour 0 (immediately after injection), 15 minutes, 1, 3, 8, 12 and 24 hours post injection ]
    Mean injection site pain over a 24 hour period post dose rated by subject on a visual analog scale (VAS), compared for injection by PFS or PFP, and for the 2 injection locations using each device
  • Injection site tolerability (Blinded Safety Assessor - Modified Draize Scale) - Mean injection site tolerability over 24 hour post dose [ Time Frame: 1, 3, 8, 12 and 24 hours post injection ]
    Mean injection site tolerability using the Modified Draize Scale Numerical Grade over 24 hours post dose rated by the blinded Safety Assessor, compared for injection by PFS or PFP, and for the 2 injection locations using each device
  • Time to reach the maximum serum concentration (Tmax) [ Time Frame: Day 1 - Day 43 ]
  • AUC from time 0 to the last time point with quantifiable concentration (AUCT) [ Time Frame: Day 1 - Day 43 ]
  • AUC extrapolated to infinity (AUC0 inf) [ Time Frame: Day 1 - Day 43 ]
  • Volume of distribution (Vz/F), [ Time Frame: Day 1 - Day 43 ]
  • Apparent clearance (CL/F) [ Time Frame: Day 1 - Day 43 ]
  • Terminal half life (t1/2) [ Time Frame: Day 1 - Day 43 ]
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 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects
Official Title  ICMJE A Phase 1, Open-label, Randomized, Single Dose, Parallel Group Comparability Study To Assess The Pharmacokinetics Of Pf-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects
Brief Summary This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC) injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Device: PF-06410293 PFS
    PF-06410293 40 mg administered subcutaneously by Prefilled syringe
  • Device: PF-06410293 PFP
    PF-06410293 40 mg administered subcutaneously by prefilled pen
Study Arms  ICMJE
  • Active Comparator: PF-06410293 PFS (Prefilled Syringe)
    PF-06410293 40 mg administered by Prefilled Syringe (PFS)
    Intervention: Device: PF-06410293 PFS
  • Active Comparator: PF-06410293 PFP (Prefilled Pen)
    PF-06410293 40 mg administered by Prefilled pen
    Intervention: Device: PF-06410293 PFP
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: October 7, 2015)
164
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy female subjects and/or male subjects, who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG), and clinical laboratory tests.
  2. Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 pounds).
  3. Chest X ray with no evidence of current, active TB or previous (inactive) TB, fungal or 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.
  4. Female subjects of non childbearing potential must meet at least one of the following criteria: a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the post menopausal state; b. Have undergone a documented hysterectomy and/or bilateral oophorectomy; c. Have medically confirmed ovarian failure.

All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.

Exclusion Criteria:

  1. 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).
  2. Evidence or history of nervous system demyelinating diseases (including multiple sclerosis, optic neuritis, Guillain Barré syndrome).
  3. History of relevant orthostatic hypotension, fainting spells or blackouts.
  4. 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 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 NCT02572245
Other Study ID Numbers  ICMJE B5381005
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 June 2016

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