Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT02222168
Status:
COMPLETED
Last Update Posted:
2024-07-31
First Post:
2014-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of BI 409306 After a High Fat, High Caloric Meal and After a Single Oral Dose Given at Bed Time in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630656', 'term': 'BI 409306'}]}}, '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': 'From first administration of BI 409306 up to 24 hours thereafter for each treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'BI 409306 Fasted', 'description': 'Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 1, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BI 409306 Fed', 'description': 'Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 4, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BI 409306 at Bed-time', 'description': 'Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 1, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bladder discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Measured Concentration of BI 409306 in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 409306 Fasted', 'description': 'Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition.'}, {'id': 'OG001', 'title': 'BI 409306 Fed', 'description': 'Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition.'}, {'id': 'OG002', 'title': 'BI 409306 at Bed-time', 'description': 'Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time'}], 'classes': [{'categories': [{'measurements': [{'value': '183', 'spread': '118', 'groupId': 'OG000'}, {'value': '175', 'spread': '69.5', 'groupId': 'OG001'}, {'value': '150', 'spread': '119', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio (Fed/Fasted)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.90', 'ciLowerLimit': '72.593', 'ciUpperLimit': '126.682', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '50.7', 'estimateComment': 'The estimated parameter was the adjusted geometric mean ratios \\[%\\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \\[%\\].', 'groupDescription': 'No formal hypothesis was tested.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio (Bed time/Fasted)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '82.13', 'ciLowerLimit': '66.370', 'ciUpperLimit': '101.639', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '38.0', 'estimateComment': 'The estimated parameter was the adjusted geometric mean ratios \\[%\\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \\[%\\].', 'groupDescription': 'No formal hypothesis was tested.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed."}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h', 'description': 'Cmax is the maximum measured concentration of BI 409306 in plasma. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C', 'unitOfMeasure': 'Nanomole per litre', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic set (PKS): This set included all treated subjects who provided at least one observation for at least one primary endpoint without important protocol violations with respect to the statistical evaluation of PK endpoints. All 18 subjects were included in the PKS.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve of BI 409306 in Plasma From Time 0 to Time of Last Quantifiable Data Point (AUC0-tz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 409306 Fasted', 'description': 'Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition.'}, {'id': 'OG001', 'title': 'BI 409306 Fed', 'description': 'Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition.'}, {'id': 'OG002', 'title': 'BI 409306 at Bed-time', 'description': 'Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time'}], 'classes': [{'categories': [{'measurements': [{'value': '273', 'spread': '118', 'groupId': 'OG000'}, {'value': '293', 'spread': '96.4', 'groupId': 'OG001'}, {'value': '259', 'spread': '117', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio (Fed/Fasted)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '107.41', 'ciLowerLimit': '96.697', 'ciUpperLimit': '119.318', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.2', 'estimateComment': 'The estimated parameter was the adjusted geometric mean ratios \\[%\\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \\[%\\].', 'groupDescription': 'No formal hypothesis was tested.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio (Bed time/Fasted)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '94.88', 'ciLowerLimit': '85.028', 'ciUpperLimit': '105.875', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '19.1', 'estimateComment': 'The estimated parameter was the adjusted geometric mean ratios \\[%\\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \\[%\\].', 'groupDescription': 'No formal hypothesis was tested.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed."}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h', 'description': 'AUC0-tz is the area under the concentration-time curve of the BI 409306 in plasma from time 0 to time of last quantifiable data point.\n\nMore detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C', 'unitOfMeasure': 'Hour times nanomole per litre', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic set (PKS): This set included all treated subjects who provided at least one observation for at least one primary endpoint without important protocol violations with respect to the statistical evaluation of PK endpoints. All 18 subjects were included in the PKS.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 409306 Fasted', 'description': 'Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition.'}, {'id': 'OG001', 'title': 'BI 409306 Fed', 'description': 'Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition.'}, {'id': 'OG002', 'title': 'BI 409306 at Bed-time', 'description': 'Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time'}], 'classes': [{'categories': [{'measurements': [{'value': '273', 'spread': '118', 'groupId': 'OG000'}, {'value': '293', 'spread': '96.3', 'groupId': 'OG001'}, {'value': '259', 'spread': '116', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio (Fed/Fasted)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '107.41', 'ciLowerLimit': '96.709', 'ciUpperLimit': '119.301', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.2', 'estimateComment': 'The estimated parameter was the adjusted geometric mean ratios \\[%\\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \\[%\\].', 'groupDescription': 'No formal hypothesis was tested.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio (Bed time/Fasted)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '94.92', 'ciLowerLimit': '85.061', 'ciUpperLimit': '105.921', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '19.1', 'estimateComment': 'The estimated parameter was the adjusted geometric mean ratios \\[%\\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \\[%\\].', 'groupDescription': 'No formal hypothesis was tested.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed."}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h', 'description': 'AUC0-infinity is the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.\n\nMore detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C.', 'unitOfMeasure': 'Hour times nanomole per litre', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic set (PKS): This set included all treated subjects who provided at least one observation for at least one primary endpoint without important protocol violations with respect to the statistical evaluation of PK endpoints. All 18 subjects were included in the PKS.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BI 409306 Fasted/Fed/Bed Time', 'description': 'Single oral dose of 25 milligram (mg) BI 409306 film-coated tablet, with 240 millilitre (ml) water in the morning under fasted then under fed condition and last administered at bed-time with a washout period of at least 3 days between the administrations.'}, {'id': 'FG001', 'title': 'BI 409306 Fed/Fasted/Bed Time', 'description': 'Single oral dose of 25 mg BI 409306 film-coated tablet, with 240 ml water in the morning under fed then under fast condition and last administered at bed-time with a washout period of at least 3 days between the administrations.'}], 'periods': [{'title': 'Period 1 (Fasted or Fed)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2 (Fasted or Fed)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 3 (Bed-time)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Eighteen healthy subjects were entered and treated and completed the planned observation time. All 18 subjects received study medication (open-label) under fasted (Treatment A) and fed (Treatment B) conditions in a two-way crossover fashion followed by a fixed sequence administered at bed time (Treatment C).', 'preAssignmentDetails': 'All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that the subject met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BI 409306 Fasted/Fed/Bed Time', 'description': 'Single oral dose of 25 mg BI 409306 film-coated tablet, with 240 ml water in the morning under fasted then under fed condition and last administered at bed-time with a washout period of at least 3 days between the administrations.'}, {'id': 'BG001', 'title': 'BI 409306 Fed/Fasted/Bed Time', 'description': 'Single oral dose of 25 mg BI 409306 film-coated tablet, with 240 ml water in the morning under fed then under fast condition and last administered at bed-time with a washout period of at least 3 days between the administrations.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '44.3', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '37.3', 'spread': '10.3', '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': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The treated set (TS): This set included all subjects who received at least one dose of trial medication. It was used for the analysis of safety, demographic data, baseline characteristics, and disposition. The TS included all 18 subjects.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2014-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2014-08-20', 'resultsFirstSubmitDate': '2023-08-10', 'studyFirstSubmitQcDate': '2014-08-20', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-10', 'studyFirstPostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Measured Concentration of BI 409306 in Plasma (Cmax)', 'timeFrame': 'Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h', 'description': 'Cmax is the maximum measured concentration of BI 409306 in plasma. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C'}, {'measure': 'Area Under the Concentration-time Curve of BI 409306 in Plasma From Time 0 to Time of Last Quantifiable Data Point (AUC0-tz)', 'timeFrame': 'Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h', 'description': 'AUC0-tz is the area under the concentration-time curve of the BI 409306 in plasma from time 0 to time of last quantifiable data point.\n\nMore detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)', 'timeFrame': 'Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h', 'description': 'AUC0-infinity is the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.\n\nMore detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C.'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of food on the pharmacokinetics of BI 409306 and to investigate the pharmacokinetics of BI 409306 when given at bed time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Healthy male and female volunteers\n2. Age 18 (incl.) to 50 (incl.) years\n3. Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2\n\nExclusion criteria:\n\n1. Any evidence of a clinically relevant concomitant disease\n2. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance\n3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n4. Surgery of the gastrointestinal tract (except appendectomy)\n5. Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders)\n6. History or evidence of relevant orthostatic reaction, fainting spells or blackouts, occurrence of syncopes, brady- or tachycardia in the anamnesis.\n7. Positive pregnancy test\n8. No adequate contraception during the study and until 1 month of study completion, i.e. intrauterine device (IUD), sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)'}, 'identificationModule': {'nctId': 'NCT02222168', 'briefTitle': 'Pharmacokinetics of BI 409306 After a High Fat, High Caloric Meal and After a Single Oral Dose Given at Bed Time in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Open, Randomised, Two-way Crossover Study to Assess the Effect of a High Fat, High Caloric Meal on the Pharmacokinetics of BI 409306, Followed by a Fixed Sequence Period to Investigate the Pharmacokinetics of BI 409306 After a Single Oral Dose Given at Bed Time in Healthy Male and Female Volunteers', 'orgStudyIdInfo': {'id': '1289.22'}, 'secondaryIdInfos': [{'id': '2014-001934-28', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 409306 fasted', 'description': 'Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition.', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 fed', 'description': 'Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition.', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 at bed-time', 'description': 'Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time.', 'interventionNames': ['Drug: BI 409306']}], 'interventions': [{'name': 'BI 409306', 'type': 'DRUG', 'description': 'film-coated tablet', 'armGroupLabels': ['BI 409306 at bed-time', 'BI 409306 fasted', 'BI 409306 fed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': '1289.22.1 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https:// www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}