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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

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

Condition or disease Intervention/treatment Phase
Healthy Subjects Device: PF-06410293 PFS Device: PF-06410293 PFP Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : January 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Active Comparator: PF-06410293 PFS (Prefilled Syringe)
PF-06410293 40 mg administered by Prefilled Syringe (PFS)
Device: PF-06410293 PFS
PF-06410293 40 mg administered subcutaneously by Prefilled syringe

Active Comparator: PF-06410293 PFP (Prefilled Pen)
PF-06410293 40 mg administered by Prefilled pen
Device: PF-06410293 PFP
PF-06410293 40 mg administered subcutaneously by prefilled pen




Primary Outcome Measures :
  1. Maximum serum concentration (Cmax) [ Time Frame: Day 1 - Day 15 ]
  2. Area under the concentration curve (AUC 0-2wk) [ Time Frame: Day 1-Day 15 ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. Time to reach the maximum serum concentration (Tmax) [ Time Frame: Day 1 - Day 43 ]
  4. AUC from time 0 to the last time point with quantifiable concentration (AUCT) [ Time Frame: Day 1 - Day 43 ]
  5. AUC extrapolated to infinity (AUC0 inf) [ Time Frame: Day 1 - Day 43 ]
  6. Volume of distribution (Vz/F), [ Time Frame: Day 1 - Day 43 ]
  7. Apparent clearance (CL/F) [ Time Frame: Day 1 - Day 43 ]
  8. Terminal half life (t1/2) [ Time Frame: Day 1 - Day 43 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02572245


Locations
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United States, Texas
ICON Early Phase Services, LLC
San Antonio, Texas, United States, 78209
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: NCT02572245     History of Changes
Other Study ID Numbers: B5381005
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016
Keywords provided by Pfizer:
Healthy Subjects
Device
PK
Phase 1
Bioequivalence
Adalimumab
Single Dose