A Study to Compare Pharmacokinetics (PK) of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD) or an Auto-injector (AI)



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:12/5/2018
Start Date:December 7, 2016
End Date:April 9, 2018

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A Randomized, Open-Label, 2-Part, 2-Arm, Parallel-Group, Single-Dose, Multi-Center Study in Healthy Subjects to Investigate the Comparability of Pharmacokinetics of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device or an Auto-Injector

This is a randomized, 2-part, 2-arm, open-label, parallel-group, multi-center study to
compare the PK of etrolizumab administered subcutaneously by an AI (test device) or a PFS-NSD
(reference device) in healthy participants. The study will comprise a pilot cohort (Part 1)
to estimate the geometric mean ratio (GMR) and variability of the maximum observed
concentration (Cmax) and area under the concentration-time curve (AUC) to confirm or
determine the sample size for the pivotal cohort (Part 2). The pivotal cohort will
demonstrate exposure comparability of Cmax, AUC from Hour 0 to the last measurable
concentration (AUClast), and AUC from Hour 0 to extrapolated infinite time (AUC0-inf), values
for a single dose of etrolizumab administered subcutaneously either by the AI or the PFS-NSD.


Inclusion Criteria:

- Within the body weight range of 60 to 100 kilograms, inclusive (for the pivotal cohort
[Part 2] only)

- Within body mass index (BMI) range 18.0 to 30.0 kilograms per square meter (kg/m^2),
inclusive

- In good health, determined by no clinically significant findings from medical history,
physical examination, 12-lead electrocardiogram (ECG), and vital signs

- Females will be non-pregnant, non-lactating, and either postmenopausal (at least 12
months of non-therapy-induced amenorrhea)/surgically sterile (e.g., tubal ligation,
hysterectomy) for at least 90 days prior to enrolment, or agree to remain
abstinent/use a highly effective method of contraception for at least 24 weeks after
study drug administration

- Males will either be sterile or agree to remain abstinent/use a highly effective
method of contraception for at least 24 weeks after study drug administration. Male
participants will refrain from sperm donation from Check-in (Day -1) until 24 weeks
following study drug administration

Exclusion Criteria:

- Any prior treatment with etrolizumab or other anti-integrin agents (including
natalizumab, vedolizumab, and efalizumab)

- Any prior treatment with anti-mucosal addressin cell adhesion molecule 1
(anti-MAdCAM-1) agents

- Any prior treatment with rituximab

- Received intravenous corticosteroids within 30 days prior to Screening

- Use of agents that deplete B or T cells (e.g., alemtuzumab, rituximab, or visilizumab)
within 12 months prior to randomization

- Any prior immunosuppressive agents (including cyclosporine, tacrolimus, sirolimus,
mycophenolate mofetil)

- Chronic nonsteroidal anti-inflammatory drug (NSAID) use

- Use of any prescription medications/products within 14 days prior to Check in (Day -1)

- History of demyelinating disease

- Neurological conditions or diseases

- History of cancer

- History of alcoholism or drug addiction within less than (<) 1 year prior to Screening

- History of active or latent tuberculosis (TB), regardless of treatment history

- History of recurrent opportunistic infections and/or history of severe disseminated
viral infections

- Positive for human immunodeficiency virus (HIV) antibody

- Any current or recent signs or symptoms of infection

- Pregnant or lactating

- Hospitalized within 4 weeks prior to and during Screening

- History of organ transplant

- Presence of skin rash at Screening or history of other skin disorders

- Tattoos, scars, chronic rashes, or sunburn in the area of the designated injection
site
We found this trial at
4
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1900 Mason Avenue
Daytona Beach, Florida 32117
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Daytona Beach, FL
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1341 West Mockingbird Lane
Dallas, Texas 75247
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Dallas, TX
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617 Oakley Street
Evansville, Indiana 47710
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Evansville, IN
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Madison, Wisconsin 53718
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Madison, WI
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