Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-30 @ 2:52 AM
Study NCT ID:
NCT03961295
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2019-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C543529', 'term': 'vedolizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than Day 127', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Group A: Vedolizumab SC PFS', 'description': 'Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Group B: Vedolizumab SC Investigational Device', 'description': 'Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Injection site paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Vedolizumab SC PFS', 'description': 'Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1.'}, {'id': 'OG001', 'title': 'Group B: Vedolizumab SC Investigational Device', 'description': 'Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '433.4', 'spread': '38.3', 'groupId': 'OG000'}, {'value': '560.3', 'spread': '26.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric LSMs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.2984', 'ciLowerLimit': '1.0786', 'ciUpperLimit': '1.5486', 'groupDescription': 'Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of variance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to Day 127) post-dose', 'unitOfMeasure': 'microgram*day per milliliter(mcg*day/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) set included all participants who received study drug and had at least 1 measurable serum concentration.'}, {'type': 'PRIMARY', 'title': 'AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Vedolizumab SC PFS', 'description': 'Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1.'}, {'id': 'OG001', 'title': 'Group B: Vedolizumab SC Investigational Device', 'description': 'Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '446.5', 'spread': '36.2', 'groupId': 'OG000'}, {'value': '594.0', 'spread': '23.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric LSMs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.3274', 'ciLowerLimit': '1.1147', 'ciUpperLimit': '1.5807', 'groupDescription': 'Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to Day 127) post-dose', 'unitOfMeasure': 'mcg*day/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who received study drug and had at least 1 measurable serum concentration.'}, {'type': 'PRIMARY', 'title': 'Cmax: Maximum Observed Serum Concentration for Vedolizumab SC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Vedolizumab SC PFS', 'description': 'Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1.'}, {'id': 'OG001', 'title': 'Group B: Vedolizumab SC Investigational Device', 'description': 'Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.70', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '16.53', 'spread': '26.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric LSMs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1978', 'ciLowerLimit': '1.0394', 'ciUpperLimit': '1.3804', 'groupDescription': 'Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to Day 127) post-dose', 'unitOfMeasure': 'microgram per milliliter (mcg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who received study drug and had at least 1 measurable serum concentration.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A: Vedolizumab SC PFS', 'description': 'Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1.'}, {'id': 'FG001', 'title': 'Group B: Vedolizumab SC Investigational Device', 'description': 'Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 1 investigative site in the United states from 22 February 2018 to 28 August 2018.', 'preAssignmentDetails': '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).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A: Vedolizumab SC PFS', 'description': 'Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1.'}, {'id': 'BG001', 'title': 'Group B: Vedolizumab SC Investigational Device', 'description': 'Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.2', 'spread': '13.55', 'groupId': 'BG000'}, {'value': '33.6', 'spread': '12.52', 'groupId': 'BG001'}, {'value': '35.4', 'spread': '12.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '71.35', 'spread': '11.614', 'groupId': 'BG000'}, {'value': '69.26', 'spread': '10.637', 'groupId': 'BG001'}, {'value': '70.30', 'spread': '10.944', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170.4', 'spread': '10.08', 'groupId': 'BG000'}, {'value': '171.0', 'spread': '7.94', 'groupId': 'BG001'}, {'value': '170.7', 'spread': '8.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '24.558', 'spread': '3.2381', 'groupId': 'BG000'}, {'value': '23.603', 'spread': '2.7232', 'groupId': 'BG001'}, {'value': '24.080', 'spread': '2.9663', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The safety analysis set included all participants who were enrolled and received 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-11', 'size': 1250285, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-07-09T18:34', 'hasProtocol': True}, {'date': '2018-05-24', 'size': 748279, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-07-09T18:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-29', 'studyFirstSubmitDate': '2019-05-22', 'resultsFirstSubmitDate': '2019-07-09', 'studyFirstSubmitQcDate': '2019-05-22', 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-09', 'studyFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to Day 127) post-dose'}, {'measure': 'AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to Day 127) post-dose'}, {'measure': 'Cmax: Maximum Observed Serum Concentration for Vedolizumab SC', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to Day 127) post-dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.', 'detailedDescription': '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.\n\nThis 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:\n\n* Group A: Vedolizumab SC PFS\n* Group B: Vedolizumab SC Investigational Device\n\nAll participants will receive a single dose of study drug on Day 1.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. 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.\n\nExclusion Criteria:\n\n1. Has received any investigational or approved biologic or biosimilar within 30 days or 5 half-lives, of Screening, whichever is longer.\n2. Has had prior exposure to vedolizumab, or has hypersensitivity to vedolizumab or any of its components.\n3. 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.\n4. Has 1 or more positive responses on the PML subjective symptom checklist at screening or before dosing on Day 1.\n5. 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.\n6. Has evidence of an active infection during the Screening Period.\n7. Has received any live vaccinations within 30 days before Screening.\n8. Has active or latent tuberculosis (TB) as evidenced by the following:\n\n o A diagnostic TB test performed within 30 days of Screening or during the Screening Period that is positive, defined as:\n 1. Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR\n 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.\n\n Note: Participants with documented previously treated TB with a negative QuantiFERON test can be included in the study.\n9. Has poor peripheral venous access.\n10. Is unable to attend all the study visits or comply with study procedures.\n11. 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.'}, 'identificationModule': {'nctId': 'NCT03961295', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'VedolizumabSC-1021'}, 'secondaryIdInfos': [{'id': 'U1111-1205-7156', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A: Vedolizumab SC PFS', 'description': 'Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.', 'interventionNames': ['Drug: Vedolizumab SC']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: Vedolizumab SC Investigational Device', 'description': 'Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.', 'interventionNames': ['Drug: Vedolizumab SC']}], 'interventions': [{'name': 'Vedolizumab SC', 'type': 'DRUG', 'otherNames': ['ENTYVIO, KYNTELES, MLN0002'], 'description': 'Vedolizumab SC liquid.', 'armGroupLabels': ['Group A: Vedolizumab SC PFS', 'Group B: Vedolizumab SC Investigational Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', '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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}