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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000927-26 | EudraCT Number | ||
| U1111-1152-6903 | Registry Identifier | WHO | |
| 14/LO/0466 | Registry Identifier | NRES |
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The purpose of this study is to assess the absolute bioavailability and pharmacokinetics of vedolizumab following a single injection of vedolizumab subcutaneously at 3 varying doses.
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to determine its bioavailability, safety, and tolerability in the body with three varying doses of vedolizumab SC compared to people who are administered vedolizumab IV.
The study will enroll approximately 24 non-Japanese patients and 24 Japanese patients. Participants will be randomly assigned to one of the four treatment groups:
All participants will receive the treatment they are assigned on Day 1 of the study.
This single-center trial will be conducted in the United Kingdom. The overall time to participate in this study is up to 196 days. Participants will make 10 visits to the clinic, including one 8 day period of confinement to the clinic, and will be contacted by telephone at Study Day 168 (+/-3), approximately 6 months after dose for a follow-up questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vedolizumab SC 54 mg | Experimental | Vedolizumab SC, once on Day 1. |
|
| Vedolizumab SC 108 mg | Experimental | Vedolizumab SC, once on Day 1. |
|
| Vedolizumab SC 160 mg | Experimental | Vedolizumab SC, once on Day 1. |
|
| Vedolizumab IV 300 mg | Active Comparator | Vedolizumab IV, once on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vedolizumab SC | Drug | Vedolizumab injection, for subcutaneous use (vedolizumab SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Population Mean Estimate for Bioavailability Following Subcutaneous (SC) Administration | Bioavailability is defined as the rate and extent to which the active moiety of the e.g. subcutaneous administered drug reaches the systemic circulation. Population mean estimate for bioavailability was based on population pharmacokinetic (PK) analysis to find one measure. The exposure data were pooled across visits and subjects to identify population PK parameter estimates and covariate effects. The outcome measure data was planned to be analyzed using a model collating all arms measures to report pooled data across arms, as per planned analysis. Bioavailability was estimated using population pharmacokinetic (popPK) analysis. | Day 1: predose and on multiple time points (up to Day 127) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London | NW10 7EW | United Kingdom | ||||
Healthy participants of age group 18 years to 60 years were enrolled in 1 of the 4 treatment groups: Vedolizumab intravenous 300 milligram (mg); Vedolizumab subcutaneous 54 mg; Vedolizumab SC 108 mg and Vedolizumab SC 160 mg.
Participants took part in the study at 1 investigative site in the United Kingdom from 09 June 2014 to 16 January 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vedolizumab Intravenous 300 mg | Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days. |
| FG001 | Vedolizumab Subcutaneous 54 mg | Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days. |
| FG002 | Vedolizumab Subcutaneous 108 mg | Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days. |
| FG003 | Vedolizumab Subcutaneous 160 mg | Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety analysis set included all randomized participants who received study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vedolizumab Intravenous 300 mg | Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days. |
| BG001 | Vedolizumab Subcutaneous 54 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Population Mean Estimate for Bioavailability Following Subcutaneous (SC) Administration | Bioavailability is defined as the rate and extent to which the active moiety of the e.g. subcutaneous administered drug reaches the systemic circulation. Population mean estimate for bioavailability was based on population pharmacokinetic (PK) analysis to find one measure. The exposure data were pooled across visits and subjects to identify population PK parameter estimates and covariate effects. The outcome measure data was planned to be analyzed using a model collating all arms measures to report pooled data across arms, as per planned analysis. Bioavailability was estimated using population pharmacokinetic (popPK) analysis. | The pharmacokinetic analysis set included all randomized participants who received study treatment and who had at least 1 measurable pharmacokinetic concentration. | Posted | Number | 95% Confidence Interval | percentage of drug | Day 1: predose and on multiple time points (up to Day 127) |
|
Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 168 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 | Vedolizumab Intravenous 300 mg | Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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|
| Vedolizumab IV | Drug | Vedolizumab injection, for intravenous use (vedolizumab IV) |
|
|
| London |
| United Kingdom |
Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
| BG002 | Vedolizumab Subcutaneous 108 mg | Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days. |
| BG003 | Vedolizumab Subcutaneous 160 mg | Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Weight | Mean | Standard Deviation | kilogram (kg) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
| Smoking Classification | Number | participants |
|
| Alcohol Classification | Number | participants |
|
| Female Reproductive Status | Female reproductive status was classified as postmenopausal female and female of childbearing potential. None of the female was reported as surgically sterile. | Number | participants |
|
| Vedolizumab Subcutaneous |
Vedolizumab 54 mg or 108 mg or 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days. |
|
|
| 0 |
| 12 |
| 9 |
| 12 |
| EG001 | Vedolizumab Subcutaneous 54 mg | Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days. | 0 | 12 | 8 | 12 |
| EG002 | Vedolizumab Subcutaneous 108 mg | Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days. | 0 | 12 | 11 | 12 |
| EG003 | Vedolizumab Subcutaneous 160 mg | Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days. | 0 | 12 | 8 | 12 |
| Presyncope | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Vessel puncture site swelling | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Urine odour abnormal | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.