Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT01374802
Status:
COMPLETED
Last Update Posted:
2015-07-31
First Post:
2011-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069454', 'term': 'Darunavir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'C552340', 'term': 'faldaprevir'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) occurring up to 9 days after first drug administration of DRV/r were assigned to the treatment DRV/r and AEs occurring up to 13 days after last drug administration of DRV/r+FDV were assigned to the combined treatment DRV/r+FDV.', 'description': 'The subjects were required to spontaneously report any AEs. In addition, subjects were assessed regularly for AEs during the trial.', 'eventGroups': [{'id': 'EG000', 'title': 'Darunavir+Ritonavir', 'description': 'oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r)once daily', 'otherNumAtRisk': 14, 'otherNumAffected': 7, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Faldaprevir+Darunavir+Ritonavir', 'description': 'oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.', 'otherNumAtRisk': 14, 'otherNumAffected': 11, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUCτ,ss of Darunavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir+Ritonavir', 'description': 'oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily'}, {'id': 'OG001', 'title': 'Faldaprevir+Darunavir+Ritonavir', 'description': 'oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.'}], 'classes': [{'categories': [{'measurements': [{'value': '57200', 'spread': '29.5', 'groupId': 'OG000'}, {'value': '66000', 'spread': '39.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '115.29', 'ciLowerLimit': '101.36', 'ciUpperLimit': '131.13', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '19.4', 'estimateComment': 'the standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'investigation of relative bioavailability (no formal testing)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)', 'description': 'area under the concentration-time curve of the analyte in plasma at steadystate over a uniform dosing interval τ of darunavir.\n\nThe measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set: all subjects in the treated set who provided at least one observation for at least one primary endpoint without any important protocol violations relevant to the pharmacokinetic evaluation and who did not experience vomiting at or before 2 times median tmax.'}, {'type': 'PRIMARY', 'title': 'Cτ,ss of Darunavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir+Ritonavir', 'description': 'oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily'}, {'id': 'OG001', 'title': 'Faldaprevir+Darunavir+Ritonavir', 'description': 'oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.'}], 'classes': [{'categories': [{'measurements': [{'value': '1330', 'spread': '49.5', 'groupId': 'OG000'}, {'value': '1170', 'spread': '90.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '87.91', 'ciLowerLimit': '68.609', 'ciUpperLimit': '112.630', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '38.3', 'estimateComment': 'the standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'investigation of relative bioavailability (no formal testing)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)', 'description': 'concentration of the analyte in plasma at steady-state after a uniform dosing interval τ=24h of darunavir', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'PRIMARY', 'title': 'Cmax,ss of Darunavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir+Ritonavir', 'description': 'oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily'}, {'id': 'OG001', 'title': 'Faldaprevir+Darunavir+Ritonavir', 'description': 'oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.'}], 'classes': [{'categories': [{'measurements': [{'value': '4930', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '6330', 'spread': '26.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '128.41', 'ciLowerLimit': '115.724', 'ciUpperLimit': '142.489', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '15.6', 'estimateComment': 'the standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'investigation of relative bioavailability (no formal testing)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)', 'description': 'maximum measured concentration of the analyte in plasma at steady-state', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'SECONDARY', 'title': 'Tmax,ss of Darunavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir+Ritonavir', 'description': 'oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily'}, {'id': 'OG001', 'title': 'Faldaprevir+Darunavir+Ritonavir', 'description': 'oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'spread': '33.9', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '2.01', 'spread': '37.3', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)', 'description': 'time from last dosing to maximum concentration of the analyte in plasma at steady state', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Subjects', 'description': 'The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.\n\nPeriod 1: Darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r).\n\nPeriod 2: Faldaprevir together with DRV/r.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': 'The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.\n\nPeriod 1: darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r).\n\nPeriod 2: faldaprevir together with DRV/r.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.4', 'spread': '9.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'lastUpdateSubmitDate': '2015-07-03', 'studyFirstSubmitDate': '2011-06-08', 'resultsFirstSubmitDate': '2015-07-03', 'studyFirstSubmitQcDate': '2011-06-15', 'lastUpdatePostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-03', 'studyFirstPostDateStruct': {'date': '2011-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCτ,ss of Darunavir', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)', 'description': 'area under the concentration-time curve of the analyte in plasma at steadystate over a uniform dosing interval τ of darunavir.\n\nThe measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities'}, {'measure': 'Cτ,ss of Darunavir', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)', 'description': 'concentration of the analyte in plasma at steady-state after a uniform dosing interval τ=24h of darunavir'}, {'measure': 'Cmax,ss of Darunavir', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)', 'description': 'maximum measured concentration of the analyte in plasma at steady-state'}], 'secondaryOutcomes': [{'measure': 'Tmax,ss of Darunavir', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)', 'description': 'time from last dosing to maximum concentration of the analyte in plasma at steady state'}]}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The objective of the current study is to investigate the effect of multiple oral daily doses of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Healthy male and female subjects according to the following criteria: medical history, physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram (ECG), clinical laboratory tests\n2. Age 18 to 55 years (incl.)\n3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.) and weight greater than 50 kg\n4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.\n\nExclusion criteria:\n\n1. Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and ECG) deviating from normal and of clinical relevance\n2. Any evidence of a clinically relevant concomitant disease\n3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n4. History of photosensitivity or recurrent rash.\n5. Surgery of the gastrointestinal tract (except appendectomy)\n6. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders\n7. History of relevant orthostatic hypotension, fainting spells or blackouts.\n8. Chronic or relevant acute infections\n9. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)\n10. Intake of drugs with a long half-life (more than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial\n11. Participation in another trial with an investigational drug within two months prior to administration or during the trial\n12. Smoker (more than 10 cigarettes)\n13. Inability to refrain from smoking on trial days\n14. Alcohol abuse (more than 30 g/day)\n15. Drug abuse\n16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)\n17. ALT outside the normal range or any other laboratory value outside the reference range that is of clinical relevance\n18. Inability to comply with dietary regimen of trial site\n19. The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions\n20. Positive serology tests for Human immunodeficiency virus (HIV) and hepatitis B / C virus\n21. Vulnerable subjects (e.g. persons kept in detention)'}, 'identificationModule': {'nctId': 'NCT01374802', 'briefTitle': 'Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Effect of Multiple Dosing With 240 mg QD BI 201335 on the Steady-state Pharmacokinetics of 800 mg QD Darunavir Coadministered With 100 mg QD Ritonavir (DRV/r) in Healthy Male and Female Volunteers (an Open-label, Multiple-dose, Single Group, Single Fixed Sequence Phase I Study)', 'orgStudyIdInfo': {'id': '1220.49'}, 'secondaryIdInfos': [{'id': '2011-000505-41', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 201335', 'description': 'capsule for oral administration', 'interventionNames': ['Drug: BI 201335']}, {'type': 'EXPERIMENTAL', 'label': 'Darunavir 400 mg', 'description': 'tablet for oral administration', 'interventionNames': ['Drug: Darunavir']}, {'type': 'EXPERIMENTAL', 'label': 'Ritonavir 100 mg', 'description': 'tablet for oral administration', 'interventionNames': ['Drug: Ritonavir']}], 'interventions': [{'name': 'Darunavir', 'type': 'DRUG', 'description': '400 mg tablet for oral administration', 'armGroupLabels': ['Darunavir 400 mg']}, {'name': 'Ritonavir', 'type': 'DRUG', 'description': 'tablet for oral administration', 'armGroupLabels': ['Ritonavir 100 mg']}, {'name': 'BI 201335', 'type': 'DRUG', 'armGroupLabels': ['BI 201335']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': '1220.49.1 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}