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

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Open-Label, Randomized, Parallel Group Study to Compare the Pharmacokinetics of Single Subcutaneous Injections of Vedolizumab Administered in Prefilled Syringe Versus Prefilled Syringe in Autoinjector in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961308
• Other study ID #: VedolizumabSC-1022
• Secondary ID: U1111-1205-7175
• Status: Completed
• Phase: Phase 1
• Start date: March 12, 2018
• Est. completion date: November 21, 2018

Study information

• Verified date: October 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The drug being tested in this study is called vedolizumab SC. The study will compare the PK of a vedolizumab SC in a PFS to 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 per group (a total of 204 participants), including 34 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: November 21, 2018
• Est. primary completion date: October 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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.

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 (anti-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-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.

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Vedolizumab SC
Vedolizumab SC liquid.

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC		Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Primary	AUC8: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC		Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Primary	Cmax: Maximum Observed Serum Concentration for Vedolizumab SC		Day 1 pre-dose and at multiple time points (up to Day 127) post-dose