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 Needle Safety Device (PFS+NSD) in Healthy Participants

NCT ID: NCT03948581

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-21
• Study Completion Date: 2018-09-21

Brief Summary

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.

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 versus an 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 102 participants, including 17 participants allocated to each administration site within each treatment group. Participants will be randomly assigned (per randomization schedule) 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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group A: Vedolizumab SC PFS

Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.

Group Type: ACTIVE_COMPARATOR

Vedolizumab SC

Intervention Type: DRUG

Vedolizumab SC liquid.

Group B: Vedolizumab SC Investigational Device

Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.

Group Type: EXPERIMENTAL

Vedolizumab SC

Intervention Type: DRUG

Vedolizumab SC liquid.

Interventions

Vedolizumab SC

Vedolizumab SC liquid.

Intervention Type: DRUG

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 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.

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

3. 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.

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

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

6. 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.

7. Has poor peripheral venous access.

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

9. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

Celerion

Tempe, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1205-2298

Identifier Type: OTHER

Identifier Source: secondary_id

VedolizumabSC-1018

Identifier Type: -

Identifier Source: org_study_id