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出境医 / 临床实验 / 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

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

Study Description
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.

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 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 Needle Safety Device in Healthy Subjects
Actual Study Start Date : February 21, 2018
Actual Primary Completion Date : August 14, 2018
Actual Study Completion Date : September 21, 2018
Arms and Interventions
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.
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.
Outcome Measures
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 ]

Eligibility Criteria
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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 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.
Contacts and Locations

Locations
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United States, Arizona
Celerion
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Takeda
Investigators
Layout table for investigator information
Study Director: Medical Director Takeda
Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 14, 2019
Results First Submitted Date  ICMJE August 6, 2019
Results First Posted Date  ICMJE November 18, 2019
Last Update Posted Date November 18, 2019
Actual Study Start Date  ICMJE February 21, 2018
Actual Primary Completion Date August 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
  • 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 ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • 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 ]
  • 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 ]
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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 Needle Safety Device in Healthy Subjects
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Drug: Vedolizumab SC
Vedolizumab SC liquid.
Study Arms  ICMJE
  • Active Comparator: Group A: Vedolizumab SC PFS
    Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
    Intervention: Drug: Vedolizumab SC
  • Experimental: Group B: Vedolizumab SC Investigational Device
    Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
    Intervention: Drug: Vedolizumab SC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2019) 		102
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 21, 2018
Actual Primary Completion Date August 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03948581
Other Study ID Numbers  ICMJE VedolizumabSC-1018
U1111-1205-2298 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Takeda
PRS Account Takeda
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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