A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
The purpose of this study is to compare the PK of single dose of Vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
Key facts
- Study ID
- NCT03961308
- Run by
- Takeda
- People needed
- 204
- Starts
- 2018-03-12
- Expected to finish
- 2018-11-21
- Last updated by the study team
- 2019-11-14
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Weighs greater than (>) 50 kilogram (kg) and less than (<) 90 kg or has a body mass index (BMI) from 18 to 28 kilogram per square meter (kg/m\^2), inclusive, at the time of informed consent.
You may not qualify if…
- Has had previous exposure to approved or investigational anti-integrins (example, natalizumab, efalizumab, etrolizumab, AMG 181) or anti-mucosal addressin cell adhesion molecule-1 (anti-MAdCAM-1) antibodies or rituximab.
- Has 1 or more positive responses on the PML subjective symptom checklist at screening or before dosing on Day 1.
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year before the Screening Visit or is unwilling to agree to abstain from alcohol for 7 days before Day -1 throughout confinement and for 48 hours before each clinic visit; and drugs throughout the study.
- Has evidence of an active infection during the Screening Period.
- Has received any live vaccinations within 30 days before Screening.
- Has active or latent tuberculosis (TB) as evidenced by the following:
- o A diagnostic TB test performed within 30 days of Screening or during the Screening Period that is positive, defined as:
- Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR
- A TB skin test reaction greater than or equal to (>=) 5 millimeter (mm). NOTE: If participants have received Bacillus Calmette-Gueri (BCG) vaccine then a QuantiFERON TB Gold test should be performed instead of the TB skin test.
- Note: Participants with documented previously treated TB with a negative QuantiFERON test can be included in the study.
- Has poor peripheral venous access.
- Is unable to attend all the study visits or comply with study procedures.
- Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including serum pheresis), or had a transfusion of any blood product within 45 days before Day 1.
Where it is running
- Celerion — Tempe, Arizona, United States
- Celerion — Lincoln, Nebraska, United States
Full record on ClinicalTrials.gov
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