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 |
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.
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
sites
617 Oakley Street
Evansville, Indiana 47710
Evansville, Indiana 47710
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