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

Healthy Subjects Clinical Trial

— B538-05  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572245
• Other study ID #: B5381005
• Status: Completed
• Phase: Phase 1
• First received: September 25, 2015
• Last updated: June 3, 2016
• Start date: January 2016
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Device:
• PF-06410293 PFS
PF-06410293 40 mg administered subcutaneously by Prefilled syringe
• PF-06410293 PFP
PF-06410293 40 mg administered subcutaneously by prefilled pen

Locations

Country	Name	City	State
United States	ICON Early Phase Services, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum serum concentration (Cmax)		Day 1 - Day 15	No
Primary	Area under the concentration curve (AUC 0-2wk)		Day 1-Day 15	No
Secondary	Injection site tolerability (Subject Assessment - Visual Analog Scale) - Mean Injection site pain over 24 hour period post dose	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	Hour 0 (immediately after injection), 15 minutes, 1, 3, 8, 12 and 24 hours post injection	Yes
Secondary	Injection site tolerability (Blinded Safety Assessor - Modified Draize Scale) - Mean injection site tolerability over 24 hour post dose	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	1, 3, 8, 12 and 24 hours post injection	Yes
Secondary	Time to reach the maximum serum concentration (Tmax)		Day 1 - Day 43	No
Secondary	AUC from time 0 to the last time point with quantifiable concentration (AUCT)		Day 1 - Day 43	No
Secondary	AUC extrapolated to infinity (AUC0 inf)		Day 1 - Day 43	No
Secondary	Volume of distribution (Vz/F),		Day 1 - Day 43	No
Secondary	Apparent clearance (CL/F)		Day 1 - Day 43	No
Secondary	Terminal half life (t1/2)		Day 1 - Day 43	No

External Links

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