Phase 1
Completed N=24
A Pilot 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
Healthy Volunteers
Source: ClinicalTrials.gov NCT03961295 ↗
Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Aug 2019
Primary outcomePrimary: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC — 433.4; 560.3 microgram*day per milliliter(mcg*day/mL)
Summary
The purpose of this study is to compare PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC |
433.4; 560.3 | — |
| PRIMARY AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC |
446.5; 594.0 | — |
| PRIMARY Cmax: Maximum Observed Serum Concentration for Vedolizumab SC |
13.70; 16.53 | — |
Eligibility Criteria
Inclusion Criteria
- Weighs greater than (>) 50 kilogram (kg) and less than ( =) 5 millimeter (mm). NOTE: If participants have received Bacillus Calmette-Guerin (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.
Data sourced from ClinicalTrials.gov (NCT03961295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.