Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT06132867
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2023-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Compare the Relative Bioavailability of Brigatinib When Swallowed as a Solution Versus When Swallowed as a Tablet in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000598580', 'term': 'brigatinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TrialDisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Study Director', 'organization': 'Takeda'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of the study drug up to Day 31', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment A: Brigatinib 90 mg Oral Solution', 'description': 'Participants received single dose of brigatinib 90 mg as an oral solution on Day 1 of Period 1 or 2 in a fasted state.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment B: Brigatinib 90 mg Tablet', 'description': 'Participants received single dose of brigatinib 90 mg as an immediate-release tablet on Day 1 of Period 1 or 2 in a fasted state.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Poor quality sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax: Maximum Observed Plasma Concentration for Brigatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: Brigatinib 90 mg Oral Solution', 'description': 'Participants received single dose of brigatinib 90 mg as an oral solution on Day 1 of Period 1 or 2 in a fasted state.'}, {'id': 'OG001', 'title': 'Treatment B: Brigatinib 90 mg Tablet', 'description': 'Participants received single dose of brigatinib 90 mg as an immediate-release tablet on Day 1 of Period 1 or 2 in a fasted state.'}], 'classes': [{'categories': [{'measurements': [{'value': '366.6', 'spread': '53.2', 'groupId': 'OG000'}, {'value': '397.6', 'spread': '49.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio (GMR) (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '92.2', 'ciLowerLimit': '86.98', 'ciUpperLimit': '97.74', 'estimateComment': 'GMR (%) was calculated as 100\\*(Treatment A/Treatment B).', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90 percent (%) confidence intervals (CIs) were calculated using the exponentiation of the difference between treatment least square means (LSM) from the analyses on the natural log-transformed of Cmax.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post-dose', 'unitOfMeasure': 'nanogram per millliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) analysis set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.'}, {'type': 'PRIMARY', 'title': 'AUClast: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Brigatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: Brigatinib 90 mg Oral Solution', 'description': 'Participants received single dose of brigatinib 90 mg as an oral solution on Day 1 of Period 1 or 2 in a fasted state.'}, {'id': 'OG001', 'title': 'Treatment B: Brigatinib 90 mg Tablet', 'description': 'Participants received single dose of brigatinib 90 mg as an immediate-release tablet on Day 1 of Period 1 or 2 in a fasted state.'}], 'classes': [{'categories': [{'measurements': [{'value': '6930', 'spread': '43.4', 'groupId': 'OG000'}, {'value': '7219', 'spread': '43.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '96', 'ciLowerLimit': '88.48', 'ciUpperLimit': '104.16', 'estimateComment': 'GMR (%) was calculated as 100\\*(Treatment A/Treatment B).', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90% CIs were calculated using the exponentiation of the difference between treatment LSM from the analyses on the natural log-transformed of AUClast.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post-dose', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.'}, {'type': 'PRIMARY', 'title': 'AUCinf: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity for Brigatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: Brigatinib 90 mg Oral Solution', 'description': 'Participants received single dose of brigatinib 90 mg as an oral solution on Day 1 of Period 1 or 2 in a fasted state.'}, {'id': 'OG001', 'title': 'Treatment B: Brigatinib 90 mg Tablet', 'description': 'Participants received single dose of brigatinib 90 mg as an immediate-release tablet on Day 1 of Period 1 or 2 in a fasted state.'}], 'classes': [{'categories': [{'measurements': [{'value': '7373', 'spread': '39.5', 'groupId': 'OG000'}, {'value': '7693', 'spread': '41.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.84', 'ciLowerLimit': '88.81', 'ciUpperLimit': '103.42', 'estimateComment': 'GMR (%) was calculated as 100\\*(Treatment A/Treatment B).', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90% CIs were calculated using the exponentiation of the difference between treatment LSM from the analyses on the natural log-transformed of AUCinf.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post-dose', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: Brigatinib 90 mg Oral Solution', 'description': 'Participants received single dose of brigatinib 90 mg as an oral solution on Day 1 of Period 1 or 2 in a fasted state.'}, {'id': 'OG001', 'title': 'Treatment B: Brigatinib 90 mg Tablet', 'description': 'Participants received single dose of brigatinib 90 mg as an immediate-release tablet on Day 1 of Period 1 or 2 in a fasted state.'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Participants with SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of the study drug up to Day 31', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who had signed informed consent form (ICF) to participate in a study. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an adverse event that was starting or worsening at the time of or after the first dose of brigatinib administered in the study. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly or is an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all the participants who received at least one dose of the study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence AB', 'description': 'Participants received single dose of brigatinib 90 milligram (mg) as an oral solution in a fasted state on Day 1 of Period 1 (Treatment A) followed by single dose of brigatinib 90 mg as an immediate-release tablet in a fasted state on Day 1 of Period 2 (Treatment B). A washout period of at least 14 days was maintained between brigatinib administration in Period 1 and 2.'}, {'id': 'FG001', 'title': 'Sequence BA', 'description': 'Participants received single dose of brigatinib 90 mg as an immediate-release tablet in a fasted state on Day 1 of Period 1 (Treatment B) followed by single dose of brigatinib 90 mg as an oral solution in a fasted state on Day 1 of Period 2 (Treatment A). A washout period of at least 14 days was maintained between brigatinib administration in Period 1 and 2.'}], 'periods': [{'title': 'Period 1 (Day 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2 (Day 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'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 20 December 2023 to 17 February 2024.', 'preAssignmentDetails': 'A total of 12 participants entered the study and were randomized in a 1:1 ratio to one of the treatment sequences: Treatment A followed by Treatment B (AB) or Treatment B followed by Treatment A (BA).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence AB', 'description': 'Participants received single dose of brigatinib 90 milligram (mg) as an oral solution in a fasted state on Day 1 of Period 1 (Treatment A) followed by single dose of brigatinib 90 mg as an immediate-release tablet in a fasted state on Day 1 of Period 2 (Treatment B). A washout period of at least 14 days was maintained between brigatinib administration in Period 1 and 2.'}, {'id': 'BG001', 'title': 'Sequence BA', 'description': 'Participants received single dose of brigatinib 90 mg as an immediate-release tablet in a fasted state on Day 1 of Period 1 (Treatment B) followed by single dose of brigatinib 90 mg as an oral solution in a fasted state on Day 1 of Period 2 (Treatment A). A washout period of at least 14 days was maintained between brigatinib administration in Period 1 and 2.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.2', 'spread': '10.82', 'groupId': 'BG000'}, {'value': '39.3', 'spread': '8.50', 'groupId': 'BG001'}, {'value': '42.3', 'spread': '9.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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'}], 'populationDescription': 'The safety analysis set included all the participants who received at least one dose of the study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-05', 'size': 1176479, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-20T02:14', 'hasProtocol': True}, {'date': '2023-11-03', 'size': 1364160, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-20T02:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-02-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2023-11-10', 'resultsFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2023-11-10', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-20', 'studyFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax: Maximum Observed Plasma Concentration for Brigatinib', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post-dose'}, {'measure': 'AUClast: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Brigatinib', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post-dose'}, {'measure': 'AUCinf: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity for Brigatinib', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From first dose of the study drug up to Day 31', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who had signed informed consent form (ICF) to participate in a study. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an adverse event that was starting or worsening at the time of or after the first dose of brigatinib administered in the study. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly or is an important medical event.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/79d6faee75ee4a31?idFilter=%5B%22Brigatinib-1004%22%5D', 'label': 'To obtain more information on the study, click this link.'}]}, 'descriptionModule': {'briefSummary': 'The main aim of this study is to compare the amount of brigatinib in the blood of healthy adults after they have swallowed one dose either as a solution or as a tablet.', 'detailedDescription': 'The drug being tested in this study is called brigatinib. Brigatinib is being tested to assess its relative bioavailability when administered as an oral solution versus as an immediate-release tablet in healthy participants.\n\nThe study will enroll approximately 12 participants. Participants will be randomly assigned to one of the treatment sequences:\n\n* Sequence 1: Treatment A followed by Treatment B\n* Sequence 2: Treatment B followed by Treatment A wherein Treatment A is a 90 mg oral solution dose and Treatment B is a 90 mg tablet dose.\n\nThere will be a washout period of at least 14 days between brigatinib administration in each study period. The follow-up contact will occur 14 (±2) days post the last dose of study drug.\n\nThis single-center trial will be conducted in the United States. The overall study duration is approximately 56 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Continuous nonsmoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study.\n2. Body mass index (BMI) ≥18.0 and ˂32.0 kilograms per meters squared (kg/m\\^2) at screening.\n3. Pulse rate between 60 and 100 beats per minute (bpm) and a blood pressure between 90 to 140 millimeters of mercury (mmHg) systolic and 40 to 90 mmHg diastolic at screening and prior to dosing of Period 1.\n4. Creatine phosphokinase is ≤1.1x upper limit of normal \\[ULN\\]; lipase, amylase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, glucose, and activated partial thromboplastin time (aPTT) are ≤ULN at screening and check-in of Period 1.\n\nExclusion Criteria:\n\n1. Any history of major surgery.\n2. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.\n3. Unable to refrain from or anticipates the use of any drug, including prescription and nonprescription medications, herbal remedies, or vitamin supplements within 28 days prior to the first dosing and throughout the study.\n4. Positive results at screening for Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus (HCV).\n5. Positive coronavirus disease 2019 (COVID-19) results at first check-in.\n6. Donation of blood or significant blood loss within 56 days prior to the first dosing.\n7. Plasma donation within 7 days prior to the first dosing.'}, 'identificationModule': {'nctId': 'NCT06132867', 'briefTitle': 'A Study to Compare the Relative Bioavailability of Brigatinib When Swallowed as a Solution Versus When Swallowed as a Tablet in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 1, Open-Label, Randomized, Single-Dose, 2-Period, Crossover Study to Evaluate the Relative Bioavailability of Brigatinib Administered as an Oral Solution Versus an Immediate-Release Tablet in Adult Healthy Subjects', 'orgStudyIdInfo': {'id': 'Brigatinib-1004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence AB', 'description': 'Participants received single dose of brigatinib 90 milligram (mg) as an oral solution in a fasted state on Day 1 of Period 1 (Treatment A) followed by single dose of brigatinib 90 mg as an immediate-release tablet in a fasted state on Day 1 of Period 2 (Treatment B). A washout period of at least 14 days was maintained between brigatinib administration in Period 1 and 2.', 'interventionNames': ['Drug: Brigatinib']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence BA', 'description': 'Participants received single dose of brigatinib 90 mg as an immediate-release tablet in a fasted state on Day 1 of Period 1 (Treatment B) followed by single dose of brigatinib 90 mg as an oral solution in a fasted state on Day 1 of Period 2 (Treatment A). A washout period of at least 14 days was maintained between brigatinib administration in Period 1 and 2.', 'interventionNames': ['Drug: Brigatinib']}], 'interventions': [{'name': 'Brigatinib', 'type': 'DRUG', 'description': 'Brigatinib oral solution', 'armGroupLabels': ['Sequence AB', 'Sequence BA']}, {'name': 'Brigatinib', 'type': 'DRUG', 'otherNames': ['ALUNBRIG®'], 'description': 'Brigatinib tablet', 'armGroupLabels': ['Sequence AB', 'Sequence BA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Celerion, Inc.', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}