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

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
ICON Early Phase Services, LLC
San Antonio, Texas, 78209 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
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

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT02572245
Pfizer
Completed
A Study of PF-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects

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A Study of PF-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects
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
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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy Subjects
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
164
May 2016
May 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02572245
B5381005
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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