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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1202-5669 | Other Identifier | WHO |
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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Vedolizumab SC PFS | Active Comparator | Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1. |
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| Group B: Vedolizumab SC Investigational Device | Experimental | Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vedolizumab SC | Drug | Vedolizumab SC liquid. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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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Healthy participants were enrolled in one of the two device presentation groups to receive vedolizumab subcutaneous (SC) 108 milligram (mg) using prefilled syringe (PFS) or using an investigational device. Primary objective was to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
Participants took part in the study at 1 investigative site in the United States from 06 February 2018 to 13 August 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Vedolizumab SC PFS | Vedolizumab SC 108 mg, injection, subcutaneously using PFS, once on Day 1. |
| FG001 | Group B: Vedolizumab SC Investigational Device | Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 11, 2017 | Jun 28, 2019 |
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| COMPLETED |
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| NOT COMPLETED |
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The safety analysis set included all participants who were enrolled and received 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Vedolizumab SC PFS | Vedolizumab SC 108 mg, injection, subcutaneously using PFS, once on Day 1. |
| BG001 | Group B: Vedolizumab SC Investigational Device | Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kilogram (Kg) |
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| Height | Mean | Standard Deviation | centimeter (cm) |
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| Body mass index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC | The pharmacokinetic (PK) set included all participants who received study drug and had at least one measurable serum concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*day per milliliter(mcg*day/mL) | Day 1 pre-dose and at multiple time points (up to Day 127) post-dose |
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| Primary | AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC | The PK set included all participants who received study drug and had at least one measurable serum concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg*day/mL | Day 1 pre-dose and at multiple time points (up to Day 127) post-dose |
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| Primary | Cmax: Maximum Observed Serum Concentration for Vedolizumab SC | The PK set included all participants who received study drug and had at least one measurable serum concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (mcg/mL) | Day 1 pre-dose and at multiple time points (up to Day 127) post-dose |
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Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127
At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: Vedolizumab SC PFS | Vedolizumab SC 108 mg, injection, subcutaneously using PFS, once on Day 1. | 0 | 12 | 0 | 12 | 7 | 12 |
| EG001 | Group B: Vedolizumab SC Investigational Device | Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1. | 0 | 12 | 1 | 12 | 9 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Conjunctival cyst | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Retinal drusen | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Dental restoration failure | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
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| Weight increased | Investigations | MedDRA (20.1) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
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Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 5, 2018 | Jun 28, 2019 | SAP_001.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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