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

NCT03961295 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: VedolizumabSC-1021U1111-1205-7156
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (3)

• 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

• AUC∞: 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

• Cmax: Maximum Observed Serum Concentration for Vedolizumab SC

  Day 1 pre-dose and at multiple time points (up to Day 127) post-dose

Study Arms (2)

Group A: Vedolizumab SC PFS

ACTIVE COMPARATOR

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

Drug: Vedolizumab SC

Group B: Vedolizumab SC Investigational Device

EXPERIMENTAL

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

Drug: Vedolizumab SC

Interventions

Vedolizumab SC DRUG

Vedolizumab SC liquid.

Also known as: ENTYVIO, KYNTELES, MLN0002

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• Has received any investigational or approved biologic or biosimilar within 30 days or 5 half-lives, of Screening, whichever is longer.
• Has had prior exposure to vedolizumab, or has hypersensitivity to vedolizumab or any of its components.
• 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.
• Has 1 or more positive responses on the PML subjective symptom checklist at screening or before dosing on Day 1.
• 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.
• Has evidence of an active infection during the Screening Period.
• Has received any live vaccinations within 30 days before Screening.
• 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:
• Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR
• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

vedolizumab

Results Point of Contact

• Title: Medical director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 23, 2019
• Study Start: February 22, 2018
• Primary Completion: July 14, 2018
• Study Completion: August 28, 2018
• Last Updated: November 13, 2019
• Results First Posted: August 19, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)