Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT01426958
Status:
COMPLETED
Last Update Posted:
2014-06-09
First Post:
2011-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077716', 'term': 'Afatinib'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': True, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First administration of trial medication until 28 days after last administration of trial medication', 'eventGroups': [{'id': 'EG000', 'title': 'Afatinib', 'description': 'Subjects were treated with a single dose of Afatinib 40mg on Day 1.', 'otherNumAtRisk': 23, 'otherNumAffected': 2, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Afatinib + Concomittant Rtv', 'description': 'Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.', 'otherNumAtRisk': 24, 'otherNumAffected': 7, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Afatinib + Timed Rtv', 'description': 'Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.', 'otherNumAtRisk': 22, 'otherNumAffected': 5, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under Curve From 0 to tz (AUC0-tz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib', 'description': 'Subjects were treated with a single dose of Afatinib 40mg on Day 1.'}, {'id': 'OG001', 'title': 'Afatinib + Concomittant Rtv', 'description': 'Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.'}, {'id': 'OG002', 'title': 'Afatinib + Timed Rtv', 'description': 'Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '392', 'spread': '26.2', 'groupId': 'OG000'}, {'value': '478', 'spread': '27.9', 'groupId': 'OG001'}, {'value': '438', 'spread': '20.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '119.30', 'ciLowerLimit': '112.239', 'ciUpperLimit': '126.811', 'pValueComment': 'P-value for ratio outside interval 0.8-1.25', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '11.5', 'estimateComment': 'The standard deviation is actually the geometric coefficient of variation', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Adjusted geometric mean ratio', 'testedNonInferiority': True, 'nonInferiorityComment': 'Relative bioavailability'}, {'pValue': '0.0009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '110.23', 'ciLowerLimit': '103.837', 'ciUpperLimit': '117.006', 'pValueComment': 'P-value for ratio outside interval 0.8-1.25', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '10.9', 'estimateComment': 'The standard deviation is actually the geometric coefficient of variation', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Adjusted geometric mean ratio', 'testedNonInferiority': True, 'nonInferiorityComment': 'Relative bioavailability'}, {'pValue': '0.0004', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '91.90', 'ciLowerLimit': '86.519', 'ciUpperLimit': '97.614', 'pValueComment': 'P-value for ratio outside interval 0.8-1.25', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '11.6', 'estimateComment': 'The standard deviation is actually the geometric coefficient of variation', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Adjusted geometric mean ratio', 'testedNonInferiority': True, 'nonInferiorityComment': 'Relative bioavailability'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post', 'description': 'AUC0-tz represents the area under the concentration curve of the analyte in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.'}, {'type': 'PRIMARY', 'title': 'Maximum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib', 'description': 'Subjects were treated with a single dose of Afatinib 40mg on Day 1.'}, {'id': 'OG001', 'title': 'Afatinib + Concomittant Rtv', 'description': 'Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.'}, {'id': 'OG002', 'title': 'Afatinib + Timed Rtv', 'description': 'Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'spread': '33.5', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '29.4', 'groupId': 'OG001'}, {'value': '20.7', 'spread': '24.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '104.06', 'ciLowerLimit': '96.681', 'ciUpperLimit': '112.002', 'pValueComment': 'P-value for ratio outside interval 0.8-1.25', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '14.2', 'estimateComment': 'The standard deviation is actually the geometric coefficient of variation', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Adjusted geometric mean ratio', 'testedNonInferiority': True, 'nonInferiorityComment': 'Relative bioavailability'}, {'pValue': '0.0012', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.09', 'ciLowerLimit': '96.425', 'ciUpperLimit': '114.530', 'pValueComment': 'P-value for ratio outside interval 0.8-1.25', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '16.1', 'estimateComment': 'The standard deviation is actually the geometric coefficient of variation', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Adjusted geometric mean ratio', 'testedNonInferiority': True, 'nonInferiorityComment': 'Relative bioavailability'}, {'pValue': '0.0000', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.75', 'ciLowerLimit': '93.328', 'ciUpperLimit': '106.610', 'pValueComment': 'P-value for ratio outside interval 0.8-1.25', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '12.8', 'estimateComment': 'The standard deviation is actually the geometric coefficient of variation', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Adjusted geometric mean ratio', 'testedNonInferiority': True, 'nonInferiorityComment': 'Relative bioavailability'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post', 'description': 'Cmax represents the maximum concentration of the analyte in plasma.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.'}, {'type': 'PRIMARY', 'title': 'Area Under Curve From 0 to ∞ Hours (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib', 'description': 'Subjects were treated with a single dose of Afatinib 40mg on Day 1.'}, {'id': 'OG001', 'title': 'Afatinib + Concomittant Rtv', 'description': 'Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.'}, {'id': 'OG002', 'title': 'Afatinib + Timed Rtv', 'description': 'Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '426', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '515', 'spread': '27.5', 'groupId': 'OG001'}, {'value': '475', 'spread': '19.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0702', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '118.56', 'ciLowerLimit': '111.712', 'ciUpperLimit': '125.822', 'pValueComment': 'P-value for ratio outside interval 0.8-1.25', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '11.5', 'estimateComment': 'The standard deviation is actually the geometric coefficient of variation', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Adjusted geometric mean ratio', 'testedNonInferiority': True, 'nonInferiorityComment': 'Relative bioavailability'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '110.76', 'ciLowerLimit': '104.936', 'ciUpperLimit': '116.913', 'pValueComment': 'P-value for ratio outside interval 0.8-1.25', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '10.0', 'estimateComment': 'The standard deviation is actually the geometric coefficient of variation', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Adjusted geometric mean ratio', 'testedNonInferiority': True, 'nonInferiorityComment': 'Relative bioavailability'}, {'pValue': '0.0003', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '92.46', 'ciLowerLimit': '86.928', 'ciUpperLimit': '98.341', 'pValueComment': 'P-value for ratio outside interval 0.8-1.25', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '11.9', 'estimateComment': 'The standard deviation is actually the geometric coefficient of variation', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Adjusted geometric mean ratio', 'testedNonInferiority': True, 'nonInferiorityComment': 'Relative bioavailability'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post', 'description': 'AUC0-∞ represents the area under the concentration curve of the analyte in plasma from 0 extrapolated to infinity.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'This is an open-label, randomized, three-way crossover clinical phase I trial in healthy volunteers.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'This is an open-label, randomized, three-way crossover clinical phase I trial in healthy volunteers.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.0', 'spread': '8.3', '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': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2014-06-03', 'studyFirstSubmitDate': '2011-08-30', 'resultsFirstSubmitDate': '2013-08-08', 'studyFirstSubmitQcDate': '2011-08-31', 'lastUpdatePostDateStruct': {'date': '2014-06-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-29', 'studyFirstPostDateStruct': {'date': '2011-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under Curve From 0 to tz (AUC0-tz)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post', 'description': 'AUC0-tz represents the area under the concentration curve of the analyte in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte.'}, {'measure': 'Maximum Concentration (Cmax)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post', 'description': 'Cmax represents the maximum concentration of the analyte in plasma.'}, {'measure': 'Area Under Curve From 0 to ∞ Hours (AUC0-∞)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post', 'description': 'AUC0-∞ represents the area under the concentration curve of the analyte in plasma from 0 extrapolated to infinity.'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1\\. healthy male subjects\n\nExclusion criteria:\n\n1\\. any relevant deviation from healthy conditions'}, 'identificationModule': {'nctId': 'NCT01426958', 'briefTitle': 'Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Relative Bioavailability of a Single Oral Dose of 40 mg Afatinib Given Alone Compared to Concomitant and Timed Administration of Multiple Oral Doses of Ritonavir - an Open-label, Randomised, Three-way Crossover Trial in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': '1200.151'}, 'secondaryIdInfos': [{'id': '2011-001803-11', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'treatment A', 'description': '1 tablet afatinib single dose', 'interventionNames': ['Drug: afatinib']}, {'type': 'EXPERIMENTAL', 'label': 'treatment B', 'description': '2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day', 'interventionNames': ['Drug: ritonavir + afatinib']}, {'type': 'EXPERIMENTAL', 'label': 'treatment C', 'description': '2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day', 'interventionNames': ['Drug: ritonavir + afatinib']}], 'interventions': [{'name': 'afatinib', 'type': 'DRUG', 'description': 'standard therapeutic dose', 'armGroupLabels': ['treatment A']}, {'name': 'ritonavir + afatinib', 'type': 'DRUG', 'description': 'simultaneous intake of ritonavir and afatinib on second treatment day', 'armGroupLabels': ['treatment B']}, {'name': 'ritonavir + afatinib', 'type': 'DRUG', 'description': 'on the second treatment day the first ritonavir tablet will be taken 6 hours after the afatinib tablet', 'armGroupLabels': ['treatment C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Biberach', 'country': 'Germany', 'facility': '1200.151.1 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.33333, 'lon': 8.03333}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}