Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
Study NCT ID:
NCT04470908
Status:
COMPLETED
Last Update Posted:
2024-10-26
First Post:
2020-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629551', 'term': 'zanubrutinib'}, {'id': 'D017828', 'term': 'Rifabutin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@beigene.com', 'phone': '+1-877-828-5568', 'title': 'Study Director', 'organization': 'BeiGene'}, 'certainAgreement': {'otherDetails': 'BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \\& may request a further delay to protect its IP rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the date of first study drug administration to 30 days after last dose (up to 3.5 months)', 'description': 'The safety population included all subjects who received at least 1 dose of zanubrutinib', 'eventGroups': [{'id': 'EG000', 'title': 'Zanubrutinib on Day 1', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 1, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Rifabutin on Days 3 to 10', 'description': 'Once daily oral rifabutin 300 mg on Days 3 to 10', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 6, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Zanubrutinib + Rifabutin on Day 11', 'description': 'Single oral dose zanubrutinib 320 mg and once daily oral rifabutin 300 mg on Day 11', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zanubrutinib', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1 (reference)'}, {'id': 'OG001', 'title': 'Zanubrutinib + Rifabutin', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1 and after co-administration with oral rifabutin 300 mg on Day 11 (test)'}], 'classes': [{'categories': [{'measurements': [{'value': '2700', 'spread': '24.8', 'groupId': 'OG000'}, {'value': '1530', 'spread': '21.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.566', 'ciLowerLimit': '0.525', 'ciUpperLimit': '0.610', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) population included all participants who received at least 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated).'}, {'type': 'PRIMARY', 'title': 'AUC From Time Zero to Infinity (AUC0-∞) of Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zanubrutinib', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1 (reference)'}, {'id': 'OG001', 'title': 'Zanubrutinib + Rifabutin', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1 and after co-administration with oral rifabutin 300 mg on Day 11 (test)'}], 'classes': [{'categories': [{'measurements': [{'value': '2780', 'spread': '23.3', 'groupId': 'OG000'}, {'value': '1590', 'spread': '22.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.560', 'ciLowerLimit': '0.532', 'ciUpperLimit': '0.589', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated).'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zanubrutinib', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1 (reference)'}, {'id': 'OG001', 'title': 'Zanubrutinib + Rifabutin', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1 and after co-administration with oral rifabutin 300 mg on Day 11 (test)'}], 'classes': [{'categories': [{'measurements': [{'value': '489', 'spread': '38.1', 'groupId': 'OG000'}, {'value': '253', 'spread': '33.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.518', 'ciLowerLimit': '0.441', 'ciUpperLimit': '0.608', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated).'}, {'type': 'PRIMARY', 'title': 'Time to the Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zanubrutinib', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1 (reference)'}, {'id': 'OG001', 'title': 'Zanubrutinib + Rifabutin', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1 and after co-administration with oral rifabutin 300 mg on Day 11 (test)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.02'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '8.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated).'}, {'type': 'PRIMARY', 'title': 'Time of the Last Quantifiable Concentration (Tlast) of Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zanubrutinib', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1 (reference)'}, {'id': 'OG001', 'title': 'Zanubrutinib + Rifabutin', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1 and after co-administration with oral rifabutin 300 mg on Day 11 (test)'}], 'classes': [{'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '36.0'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '24.0', 'upperLimit': '36.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated).'}, {'type': 'PRIMARY', 'title': 'Apparent Terminal Elimination Half-life (t1/2) of Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zanubrutinib', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1 (reference)'}, {'id': 'OG001', 'title': 'Zanubrutinib + Rifabutin', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1 and after co-administration with oral rifabutin 300 mg on Day 11 (test)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.24', 'spread': '3.10', 'groupId': 'OG000'}, {'value': '7.00', 'spread': '4.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated).'}, {'type': 'PRIMARY', 'title': 'Apparent Oral Clearance (CL/F) of Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zanubrutinib', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1 (reference)'}, {'id': 'OG001', 'title': 'Zanubrutinib + Rifabutin', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1 and after co-administration with oral rifabutin 300 mg on Day 11 (test)'}], 'classes': [{'categories': [{'measurements': [{'value': '115', 'spread': '23.3', 'groupId': 'OG000'}, {'value': '201', 'spread': '22.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11', 'unitOfMeasure': 'Liters/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated).'}, {'type': 'PRIMARY', 'title': 'Apparent Volume of Distribution (Vz/F) of Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zanubrutinib', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1 (reference)'}, {'id': 'OG001', 'title': 'Zanubrutinib + Rifabutin', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1 and after co-administration with oral rifabutin 300 mg on Day 11 (test)'}], 'classes': [{'categories': [{'measurements': [{'value': '1080', 'spread': '68.4', 'groupId': 'OG000'}, {'value': '1750', 'spread': '70.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11', 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zanubrutinib on Day 1', 'description': 'Single oral dose zanubrutinib 320 mg on Day 1'}, {'id': 'OG001', 'title': 'Rifabutin on Days 3 to 10', 'description': 'Once daily oral rifabutin 300 mg on Days 3 to 10'}, {'id': 'OG002', 'title': 'Zanubrutinib + Rifabutin on Day 11', 'description': 'Single oral dose zanubrutinib 320 mg and once daily oral rifabutin 300 mg on Day 11'}], 'classes': [{'title': 'At least 1 treatment-emergent adverse event (TEAE)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Vital sign TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Physical examination TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Electrocardiogram TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Laboratory-related TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the date of first study drug administration to 30 days after last dose (up to 3.5 months)', 'description': 'Adverse events (AEs) and serious adverse events included for summary, AEs that start during or after the first dose, or start prior to the first dose and increases in severity after the first dose, including vital signs, physical examination, electrocardiogram, and laboratory parameters', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least 1 dose of zanubrutinib.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zanubrutinib + Rifabutin', 'description': 'Single oral dose zanubrutinib 320 mg on Days 1 and 11 in the fasted state and once daily oral rifabutin 300 mg on Days 3 to 10 with food and on Day 11 in the fasted state'}], 'periods': [{'title': 'Zanubrutinib on Day 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Rifabutin on Days 3 to 10', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Zanubrutinib + Rifabutin on Day 11', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This was a single-center study with dosing in a fixed sequence. A total of 13 participants were enrolled and 12 completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Zanubrutinib + Rifabutin', 'description': 'Single oral dose zanubrutinib 320 mg on Days 1 and 11 in the fasted state and once daily oral rifabutin 300 mg on Days 3 to 10 with food and on Day 11 in the fasted state'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.8', 'spread': '11.00', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-16', 'size': 376203, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-10T22:14', 'hasProtocol': True}, {'date': '2020-10-12', 'size': 274864, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-10T22:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2020-07-10', 'resultsFirstSubmitDate': '2023-03-10', 'studyFirstSubmitQcDate': '2020-07-10', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-10', 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Zanubrutinib', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11'}, {'measure': 'AUC From Time Zero to Infinity (AUC0-∞) of Zanubrutinib', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Zanubrutinib', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11'}, {'measure': 'Time to the Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11'}, {'measure': 'Time of the Last Quantifiable Concentration (Tlast) of Zanubrutinib', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11'}, {'measure': 'Apparent Terminal Elimination Half-life (t1/2) of Zanubrutinib', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11'}, {'measure': 'Apparent Oral Clearance (CL/F) of Zanubrutinib', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of Zanubrutinib', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Experiencing Adverse Events (AEs)', 'timeFrame': 'From the date of first study drug administration to 30 days after last dose (up to 3.5 months)', 'description': 'Adverse events (AEs) and serious adverse events included for summary, AEs that start during or after the first dose, or start prior to the first dose and increases in severity after the first dose, including vital signs, physical examination, electrocardiogram, and laboratory parameters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phase 1', 'Healthy volunteers', 'Pharmacokinetics'], 'conditions': ['Healthy', 'Male']}, 'referencesModule': {'references': [{'pmid': '37145975', 'type': 'DERIVED', 'citation': 'Tariq B, Conto S, Cohen A, Sahasranaman S, Ou YC. A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study of Zanubrutinib with Rifabutin in Healthy Volunteers. Clin Pharmacol Drug Dev. 2023 Aug;12(8):832-838. doi: 10.1002/cpdd.1250. Epub 2023 May 5.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study was to determine the effect of the moderate cytochrome P450 3A (CYP3A) inducer rifabutin on the pharmacokinetics (PK) of zanubrutinib in healthy males.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Males of any race, between 18 and 65 years of age, inclusive.\n2. Male participants in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening\n3. Must have a body mass index (BMI) between 18 and 32 kg/m\\^2\n\nKey Exclusion Criteria:\n\n1. Participants with a clinically relevant history or presence of any clinically significant disease\n2. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed)\n3. History of drug or alcohol abuse within 1 year prior to check-in\n4. Use or intended use of any nonprescription medications/products including vitamins, minerals, herbal/plant-derived preparations within 7 days prior to check-in\n5. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result and/or a positive human immunodeficiency virus (HIV) at screening\n6. Use of tobacco- or nicotine-containing products within 3 months prior to check-in\n7. Use or intended use of any prescription medications/products within 14 days prior to check-in\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04470908', 'briefTitle': 'The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males', 'organization': {'class': 'INDUSTRY', 'fullName': 'BeiGene'}, 'officialTitle': 'A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effect of the Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'BGB-3111-112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zanubrutinib + Rifabutin', 'description': 'Day 1: zanubrutinib\n\nDays 3 to 10: rifabutin\n\nDay 11: zanubrutinib and rifabutin', 'interventionNames': ['Drug: Zanubrutinib', 'Drug: Rifabutin']}], 'interventions': [{'name': 'Zanubrutinib', 'type': 'DRUG', 'otherNames': ['BGB-3111', 'Brukinsa'], 'description': 'Single oral dose of 320 mg', 'armGroupLabels': ['Zanubrutinib + Rifabutin']}, {'name': 'Rifabutin', 'type': 'DRUG', 'description': 'Oral dose of 300 mg once daily', 'armGroupLabels': ['Zanubrutinib + Rifabutin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance Clinical Research Unit', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BeiGene'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BeiGene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}