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

• Status: Completed
• Trial end date: 2018-08-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Takeda
• Treatments: Vedolizumab

Criteria

Inclusion Criteria:

1. Weighs greater than (>) 50 kilogram (kg) and less than (<) 90 kg and has a body mass index (BMI) from 18 to 28 kilogram per square meter (kg/m^2), inclusive, at the time of informed consent.

Exclusion Criteria:

1. Has received any investigational or approved biologic or biosimilar within 30 days or 5 half-lives, of Screening, whichever is longer.

2. Has had prior exposure to vedolizumab, or has hypersensitivity to vedolizumab or any of its components.

3. Has had previous exposure to approved or investigational anti-integrins (example, natalizumab, efalizumab, etrolizumab, AMG 181) or anti-mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antibodies or rituximab.

4. Has 1 or more positive responses on the PML subjective symptom checklist at screening or before dosing on Day 1.

5. 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.

6. Has evidence of an active infection during the Screening Period.

7. Has received any live vaccinations within 30 days before Screening.

8. 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:

1. Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR

2. A TB skin test reaction greater than or equal to (>=) 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.

9. Has poor peripheral venous access.

10. Is unable to attend all the study visits or comply with study procedures.

11. 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.