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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1205-7175 | 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. The study will compare the PK of a vedolizumab SC in a PFS to 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 per group (a total of 204 participants), including 34 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:
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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| 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. |
|
| 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. |
|
| 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 or 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 (anti-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 | ||
| Celerion |
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 a 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 12 March 2018 to 21 November 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Vedolizumab SC PFS | Vedolizumab SC 108 mg, injection, subcutaneously using a 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 | Aug 23, 2019 |
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| Lincoln |
| Nebraska |
| 68502 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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The safety analysis set included all participants who were enrolled and received at least 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 a 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| 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. The number of participants analyzed includes only those participants who had data available for this measure. | 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. The number of participants analyzed includes only those participants who had data available for this measure. | 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. The number of participants analyzed includes only those participants who had data available for this measure. | 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 administration 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 AEs 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 a PFS, once on Day 1. | 0 | 102 | 1 | 102 | 70 | 102 |
| EG001 | Group B: Vedolizumab SC Investigational Device | Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1. | 0 | 102 | 0 | 102 | 72 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Cerumen impaction | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Anal fissure | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Proctalgia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Tooth impacted | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Exercise tolerance decreased | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Feeling drunk | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Influenza like illness | 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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| Injection site pruritus | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Nodule | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Pain | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Bacterial vulvovaginitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Chlamydial infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Upper respiratory tract infection | 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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| Vulvovaginal candidiasis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Nerve injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
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| Weight increased | Investigations | MedDRA (20.1) | Systematic Assessment |
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| Abnormal weight gain | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | 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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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Musculoskeletal pain | 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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| Clumsiness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Fine motor skill dysfunction | 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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| Hypoaesthesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
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| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
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| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal 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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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Hot flush | Vascular 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 | Jul 5, 2018 | Aug 23, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| C543529 | vedolizumab |
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| 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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| Black or African American |
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| White, Black or African American |
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| Native Hawaiian or Pacific Islander |
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| White |
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| White, American Indian or Alaska Native |
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| White, Asian |
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| White, Native Hawaiian or Pacific Islander |
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