Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-27 @ 1:08 AM
Study NCT ID:
NCT03796260
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2019-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days])', 'description': 'The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'F1 Test Formulation', 'description': 'Participants who received a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days).', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 4, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'F06 Reference Formulation', 'description': 'Participants who received a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days).', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 3, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Parosmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Entrectinib and M5 Metabolite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'F1 Test Formulation', 'description': 'Participants who received a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days).'}, {'id': 'OG001', 'title': 'F06 Reference Formulation', 'description': 'Participants who received a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days).'}], 'classes': [{'title': 'Entrectinib', 'categories': [{'measurements': [{'value': '44000', 'spread': '52.0', 'groupId': 'OG000'}, {'value': '44900', 'spread': '50.1', 'groupId': 'OG001'}]}]}, {'title': 'M5 Metabolite', 'categories': [{'measurements': [{'value': '14400', 'spread': '51.09', 'groupId': 'OG000'}, {'value': '15000', 'spread': '50.8', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days)', 'description': 'The area under the concentration-time curve extrapolated to infinity is calculated using the formula: AUC0-inf = AUC0-t + (Ct/λz) where Ct is the last measurable concentration and λz is the apparent terminal elimination rate constant. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern.', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Population included all participants who received at least 1 dose of study drug and had at least 1 evaluable postdose pharmacokinetic (PK) sample.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'F1 Test Formulation', 'description': 'Participants who received a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days).'}, {'id': 'OG001', 'title': 'F06 Reference Formulation', 'description': 'Participants who received a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days).'}], 'classes': [{'title': 'Entrectinib', 'categories': [{'measurements': [{'value': '41200', 'spread': '50.9', 'groupId': 'OG000'}, {'value': '42100', 'spread': '48.5', 'groupId': 'OG001'}]}]}, {'title': 'M5 Metabolite', 'categories': [{'measurements': [{'value': '11600', 'spread': '49.4', 'groupId': 'OG000'}, {'value': '12600', 'spread': '48.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days)', 'description': 'The area under the concentration-time curve calculated from Hour 0 to the last measurable concentration, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern.', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Population included all participants who received at least 1 dose of study drug and had at least 1 evaluable postdose PK sample.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'F1 Test Formulation', 'description': 'Participants who received a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days).'}, {'id': 'OG001', 'title': 'F06 Reference Formulation', 'description': 'Participants who received a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days).'}], 'classes': [{'title': 'Entrectinib', 'categories': [{'measurements': [{'value': '1870', 'spread': '49.4', 'groupId': 'OG000'}, {'value': '2000', 'spread': '37.6', 'groupId': 'OG001'}]}]}, {'title': 'M5 Metabolite', 'categories': [{'measurements': [{'value': '427', 'spread': '60.8', 'groupId': 'OG000'}, {'value': '487', 'spread': '50.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days)', 'description': 'The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Population included all participants who received at least 1 dose of study drug and had at least 1 evaluable postdose PK sample.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'F1 Test Formulation', 'description': 'Participants who received a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days).'}, {'id': 'OG001', 'title': 'F06 Reference Formulation', 'description': 'Participants who received a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days])', 'description': 'An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'F1 to F06 Crossover', 'description': 'Participants first randomized to F1/F06 arm and received a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 after a standardized meal. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib F06 (reference formulation) under fed conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).'}, {'id': 'FG001', 'title': 'F06 to F1 Crossover', 'description': 'Participants first randomized to this arm received a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 after a standardized meal. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib F1 (test formulation) under fed conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'F1 to F06 Crossover', 'description': 'Participants first randomized to F1/F06 arm and received a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 after a standardized meal. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib F06 (reference formulation) under fed conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).'}, {'id': 'BG001', 'title': 'F06 to F1 Crossover', 'description': 'Participants first randomized to this arm received a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 after a standardized meal. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib F1 (test formulation) under fed conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '33.3', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '36', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Multiple', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-02', 'size': 871323, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-27T09:03', 'hasProtocol': True}, {'date': '2019-01-28', 'size': 1047541, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-01-27T09:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-25', 'studyFirstSubmitDate': '2019-01-04', 'resultsFirstSubmitDate': '2020-01-27', 'studyFirstSubmitQcDate': '2019-01-04', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-25', 'studyFirstPostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Entrectinib and M5 Metabolite', 'timeFrame': 'At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days)', 'description': 'The area under the concentration-time curve extrapolated to infinity is calculated using the formula: AUC0-inf = AUC0-t + (Ct/λz) where Ct is the last measurable concentration and λz is the apparent terminal elimination rate constant. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern.'}, {'measure': 'Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite', 'timeFrame': 'At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days)', 'description': 'The area under the concentration-time curve calculated from Hour 0 to the last measurable concentration, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern.'}, {'measure': 'Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite', 'timeFrame': 'At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days)', 'description': 'The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days])', 'description': 'An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the relative bioavailability, safety, and tolerability of entrectinib capsule formulations F1 and F06 under fed conditions in healthy adult male and female participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy in the opinion of the investigator. Healthy is defined by the absence of evidence of any active disease or clinically significant medical condition based on a detailed medical history and examination\n* Negative test results for Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus (HIV)\n* Females must not be pregnant or breastfeeding, and females of childbearing potential will agree to use highly-effective contraception. Females of childbearing potential must also agree to refrain from donating eggs during the treatment period and for 6 weeks after the final dose of study drug\n* Males must agree to use contraception and to refrain from sperm donation from check-in (Day -1 of Period 1) to 90 days after the final dose of study drug\n\nExclusion Criteria:\n\n* History of gastrointestinal surgery or other gastrointestinal disorder that might affect absorption of medicines from the gastrointestinal tract\n* Presence of a clinically significant disease, illness, medical condition or disorder, or any other medical history determined by the investigator to be clinically significant and relevant. Ongoing chronic disorders which are not considered clinically significant are permissible providing they are stable\n* Clinically significant change in health status, as judged by the investigator, or any major illness within the 4 weeks before screening, or clinically significant acute infection or febrile illness within the 14 days before screening\n* Participation in any other clinical study involving an investigational medicinal product (IMP) or device within 30 days or 5 half-lives (if known), whichever is longer, before screening'}, 'identificationModule': {'nctId': 'NCT03796260', 'briefTitle': 'A Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Randomized, Open-Label, Two-Treatment, Two-Period, Two-Way Crossover Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Subjects', 'orgStudyIdInfo': {'id': 'GP41048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'F1 to F06 Crossover', 'description': 'Participants first randomized to this arm will receive a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 after a standardized meal. This dose will be followed by a minimum 14-day washout period, after which participants will receive a single oral dose of entrectinib F06 (reference formulation) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).', 'interventionNames': ['Drug: Entrectinib Test Formulation (F1)', 'Drug: Entrectinib Reference Formulation (F06)']}, {'type': 'EXPERIMENTAL', 'label': 'F06 to F1 Crossover', 'description': 'Participants first randomized to this arm will receive a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 after a standardized meal. This dose will be followed by a minimum 14-day washout period, after which participants will receive a single oral dose of entrectinib F1 (test formulation) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).', 'interventionNames': ['Drug: Entrectinib Test Formulation (F1)', 'Drug: Entrectinib Reference Formulation (F06)']}], 'interventions': [{'name': 'Entrectinib Test Formulation (F1)', 'type': 'DRUG', 'description': 'Participants will receive a single oral dose of entrectinib F1 after completion of a standardized meal.', 'armGroupLabels': ['F06 to F1 Crossover', 'F1 to F06 Crossover']}, {'name': 'Entrectinib Reference Formulation (F06)', 'type': 'DRUG', 'description': 'Participants will receive a single oral dose of entrectinib F06 after completion of a standardized meal.', 'armGroupLabels': ['F06 to F1 Crossover', 'F1 to F06 Crossover']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance Research Unit - Daytona', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}