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CompletedNCT03949621Updated Nov 13, 2019Results posted

A 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

A Phase 1 interventional study of Vedolizumab SC in Healthy Volunteers, sponsored by Takeda. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-13.

Sponsored by Takeda · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Feb 2018, registered May 2019).
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

The drug being tested in this study is called vedolizumab SC. This study will compare the PK of a vedolizumab SC dose in PFS to an investigational device in healthy participants.

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 (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 long-term follow-up (LFTU) assessment which will involve the progressive multifocal leukoencephalopathy (PML) questionnaire survey.

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Conditions studied

  • Healthy Volunteers

Keywords

  • Drug therapy
03

In context

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    Group A: Vedolizumab SC PFS

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

    Drug: Vedolizumab SC

  • Experimental
    Group B: Vedolizumab SC Investigational Device

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

    Drug: Vedolizumab SC

Interventions

  • DrugVedolizumab SC

    Vedolizumab SC liquid.

06

What researchers measure

Primary outcomes

  1. AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC

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

  2. AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC

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

  3. Cmax: Maximum Observed Serum Concentration for Vedolizumab SC

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

07

Results

Posted Aug 12, 2019

Participant flow

Participants took part in the study at 1 investigative site in the United States from 06 February 2018 to 13 August 2018.

Participant flow — Overall Study
MilestoneGroup A: Vedolizumab SC PFSGroup B: Vedolizumab SC Investigational Device
Started1212
Completed1212
Not completed00

Outcome measures

PrimaryAUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC
Time frame:
Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Reported as:
Geometric mean · microgram*day per milliliter(mcg*day/mL)
AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC
microgram*day per milliliter(mcg*day/mL)Group A: Vedolizumab SC PFSGroup B: Vedolizumab SC Investigational Device
AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC493.5 ± 34.9485.8 ± 23.7
Statistical analysis
  • Group A: Vedolizumab SC PFS vs Group B: Vedolizumab SC Investigational Device · Ratio of geometric lsms: 0.9632 · 90% CI 0.7938 to 1.1688
PrimaryAUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC
Time frame:
Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Reported as:
Geometric mean · mcg*day/mL
AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC
mcg*day/mLGroup A: Vedolizumab SC PFSGroup B: Vedolizumab SC Investigational Device
AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC515.2 ± 34.1505.4 ± 21.7
Statistical analysis
  • Group A: Vedolizumab SC PFS vs Group B: Vedolizumab SC Investigational Device · Ratio of geometric lsms: 0.9606 · 90% CI 0.798 to 1.1562
PrimaryCmax: Maximum Observed Serum Concentration for Vedolizumab SC
Time frame:
Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Reported as:
Geometric mean · microgram per milliliter (mcg/mL)
Cmax: Maximum Observed Serum Concentration for Vedolizumab SC
microgram per milliliter (mcg/mL)Group A: Vedolizumab SC PFSGroup B: Vedolizumab SC Investigational Device
Cmax: Maximum Observed Serum Concentration for Vedolizumab SC16.46 ± 21.416.99 ± 17.2
Statistical analysis
  • Group A: Vedolizumab SC PFS vs Group B: Vedolizumab SC Investigational Device · Ratio of geometric lsms: 1.0162 · 90% CI 0.9001 to 1.1473

Adverse events

Collected over Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group A: Vedolizumab SC PFS0/12 (0%)0/12 (0%)7/12 (58.3%)
Group B: Vedolizumab SC Investigational Device0/12 (0%)1/12 (8.3%)9/12 (75%)
Most frequent serious events
Most frequent serious events
EventGroup A: Vedolizumab SC PFSGroup B: Vedolizumab SC Investigational Device
Fibula fractureInjury, poisoning and procedural complications0/121/12
Tibia fractureInjury, poisoning and procedural complications0/121/12
Most frequent other events
Showing 10 of 27
Most frequent other events
EventGroup A: Vedolizumab SC PFSGroup B: Vedolizumab SC Investigational Device
Injection site painGeneral disorders5/125/12
RhinitisInfections and infestations0/123/12
Injection site erythemaGeneral disorders2/121/12
CataractEye disorders0/121/12
Conjunctival cystEye disorders0/121/12
Dry eyeEye disorders0/121/12
Retinal drusenEye disorders0/121/12
Abdominal painGastrointestinal disorders0/121/12
ConstipationGastrointestinal disorders0/121/12
DyspepsiaGastrointestinal disorders0/121/12

Baseline characteristics

The safety analysis set included all participants who were enrolled and received 1 dose of study drug.

Age, Continuous
Age, Continuous(years)Group A: Vedolizumab SC PFSGroup B: Vedolizumab SC Investigational DeviceTotal
Mean37.8 ± 12.9346.0 ± 9.9541.9 ± 12.03
Sex: Female, Male
Sex: Female, Male(Participants)Group A: Vedolizumab SC PFSGroup B: Vedolizumab SC Investigational DeviceTotal
Female6612
Male6612
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group A: Vedolizumab SC PFSGroup B: Vedolizumab SC Investigational DeviceTotal
Hispanic or Latino8917
Not Hispanic or Latino437
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group A: Vedolizumab SC PFSGroup B: Vedolizumab SC Investigational DeviceTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander101
Black or African American112
White101121
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Group A: Vedolizumab SC PFSGroup B: Vedolizumab SC Investigational DeviceTotal
United States121224
Weight
Weight(kilogram (Kg))Group A: Vedolizumab SC PFSGroup B: Vedolizumab SC Investigational DeviceTotal
Mean70.98 ± 11.52669.45 ± 8.15870.22 ± 9.797
Height
Height(centimeter (cm))Group A: Vedolizumab SC PFSGroup B: Vedolizumab SC Investigational DeviceTotal
Mean166.8 ± 10.81167.5 ± 5.93167.2 ± 8.53
Body mass index (BMI)
Body mass index (BMI)(kilogram per square meter (kg/m^2))Group A: Vedolizumab SC PFSGroup B: Vedolizumab SC Investigational DeviceTotal
Mean25.408 ± 2.255024.685 ± 2.268725.047 ± 2.2428
08

Study locations

1 site
  • Celerion
    Tempe, Arizona 85283, United States
09

References and documents

Study documents

  • Study protocol · Dec 11, 2017
  • Statistical analysis plan · Jun 5, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03949621
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
May 14, 2019
Start date
Feb 6, 2018
Primary completion
Jul 2, 2018
Completion
Aug 13, 2018
Results posted
Aug 12, 2019
Last update
Nov 13, 2019

Study contacts

Medical Director
study director · Takeda

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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