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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT02572245

Collaborator

(none)

164

Enrollment

Location

Arms

Duration (Months)

41.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Jan 1, 2016

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Maximum serum concentration (Cmax) [Day 1 - Day 15]
Area under the concentration curve (AUC 0-2wk) [Day 1-Day 15]

Secondary Outcome Measures

Injection site tolerability (Subject Assessment - Visual Analog Scale) - Mean Injection site pain over 24 hour period post dose [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 [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) [Day 1 - Day 43]
AUC from time 0 to the last time point with quantifiable concentration (AUCT) [Day 1 - Day 43]
AUC extrapolated to infinity (AUC0 inf) [Day 1 - Day 43]
Volume of distribution (Vz/F), [Day 1 - Day 43]
Apparent clearance (CL/F) [Day 1 - Day 43]
Terminal half life (t1/2) [Day 1 - Day 43]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.
Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 pounds).
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.
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:

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).
Evidence or history of nervous system demyelinating diseases (including multiple sclerosis, optic neuritis, Guillain Barré syndrome).
History of relevant orthostatic hypotension, fainting spells or blackouts.
Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin