Clinical trial NCT03961295: 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
Official title: A Phase 1, Open-Label, Randomized, Parallel Group Pilot Study to Compare the Pharmacokinetics of Single Subcutaneous Injections of Vedolizumab Administered in Prefilled Syringe Versus Prefilled Syringe in Autoinjector in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2019-05-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: The drug being tested in this study is called vedolizumab SC. The study will assess the PK, and variability of a vedolizumab SC in a PFS vs investigational device.

This study will include 2 different device delivery presentations in 2 treatment groups. Participants in each treatment group will be randomized to one of the three administration sites: Abdomen, thigh, or arm. The study will enroll approximately 24 participants, including 4 participants allocated to each administration site within each treatment group. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:

* Group A: Vedolizumab SC PFS
* Group B: Vedolizumab SC Investigational Device

All participants will receive a single dose of study drug on Day 1.

This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 196 days. Participants will be contacted by telephone on Day 168 after their last dose of study drug for a follow-up assessment which will involve the progressive multifocal leukoencephalopathy (PML) questionnaire survey.

Eligibility 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.

Primary outcomes:
measure: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC
timeFrame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
measure: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC
timeFrame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
measure: Cmax: Maximum Observed Serum Concentration for Vedolizumab SC
timeFrame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: