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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

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ClinicalTrials.gov Identifier: NCT03961295
Recruitment Status : Completed
First Posted : May 23, 2019
Results First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Vedolizumab SC Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : February 22, 2018
Actual Primary Completion Date : July 14, 2018
Actual Study Completion Date : August 28, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Vedolizumab

Arm Intervention/treatment
Active Comparator: Group A: Vedolizumab SC PFS
Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
Drug: Vedolizumab SC
Vedolizumab SC liquid.
Other Name: ENTYVIO, KYNTELES, MLN0002

Experimental: Group B: Vedolizumab SC Investigational Device
Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
Drug: Vedolizumab SC
Vedolizumab SC liquid.
Other Name: ENTYVIO, KYNTELES, MLN0002




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961295


Locations
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United States, Nebraska
Celerion
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Study Protocol  [PDF] December 11, 2017
Statistical Analysis Plan  [PDF] May 24, 2018


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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03961295     History of Changes
Other Study ID Numbers: VedolizumabSC-1021
U1111-1205-7156 ( Other Identifier: WHO )
First Posted: May 23, 2019    Key Record Dates
Results First Posted: August 19, 2019
Last Update Posted: August 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug therapy
Additional relevant MeSH terms:
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Vedolizumab
Gastrointestinal Agents