Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT01111318
Status:
COMPLETED
Last Update Posted:
2014-06-13
First Post:
2010-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, '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': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Drug administration until 4 days after drug administration or end-of-study visit, up to 19 days', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.', 'otherNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mild', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Moderate', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.', 'otherNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Severe', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.', 'otherNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Asymptomatic bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Electrocardiogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Nitrite urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Leukocyturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve 0 to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.'}, {'id': 'OG001', 'title': 'Mild', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.'}, {'id': 'OG002', 'title': 'Moderate', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.'}, {'id': 'OG003', 'title': 'Severe', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.'}], 'classes': [{'categories': [{'measurements': [{'value': '10800', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '13800', 'spread': '38.6', 'groupId': 'OG001'}, {'value': '16100', 'spread': '26.2', 'groupId': 'OG002'}, {'value': '19000', 'spread': '27.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '123.15', 'ciLowerLimit': '98.89', 'ciUpperLimit': '153.36', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '29.0', 'estimateComment': 'Standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'Ratio calculated as mild divided by healthy', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing, investigation of relative bioavailability'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '146.97', 'ciLowerLimit': '118.02', 'ciUpperLimit': '183.02', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '29.0', 'estimateComment': 'Standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'Ratio calculated as moderate divided by healthy', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing, investigation of relative bioavailability'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '174.70', 'ciLowerLimit': '140.29', 'ciUpperLimit': '217.55', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '29.0', 'estimateComment': 'Standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'Ratio calculated as severe divided by healthy', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing, investigation of relative bioavailability'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': "Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.\n\nThe standard deviation is actually the coefficient of variation. 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The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.", 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 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'OG001'}, {'value': '15800', 'spread': '25.7', 'groupId': 'OG002'}, {'value': '18600', 'spread': '23.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.', 'description': 'Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.\n\nThe standard deviation is actually the coefficient of variation.', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.'}, {'type': 'SECONDARY', 'title': 'Time From Dosing to Maximum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.'}, {'id': 'OG001', 'title': 'Mild', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.'}, {'id': 'OG002', 'title': 'Moderate', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.'}, {'id': 'OG003', 'title': 'Severe', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'spread': '50.1', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '1.50', 'spread': '73.2', 'groupId': 'OG001', 'lowerLimit': '0.67', 'upperLimit': '4.00'}, {'value': '2.00', 'spread': '64.4', 'groupId': 'OG002', 'lowerLimit': '0.67', 'upperLimit': '2.50'}, {'value': '1.50', 'spread': '48.2', 'groupId': 'OG003', 'lowerLimit': '0.67', 'upperLimit': '2.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.', 'description': 'Time from dosing to maximum concentration of empagliflozin (empa) in plasma.', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.'}, {'type': 'SECONDARY', 'title': 'Terminal Rate Constant (λz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.'}, {'id': 'OG001', 'title': 'Mild', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.'}, {'id': 'OG002', 'title': 'Moderate', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.'}, {'id': 'OG003', 'title': 'Severe', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0414', 'spread': '41.6', 'groupId': 'OG000'}, {'value': '0.0404', 'spread': '23.5', 'groupId': 'OG001'}, {'value': '0.0454', 'spread': '28.9', 'groupId': 'OG002'}, {'value': '0.0506', 'spread': '41.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Terminal rate constant in plasma.\n\nThe standard deviation is actually the coefficient of variation.', 'unitOfMeasure': '1/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-Life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.'}, {'id': 'OG001', 'title': 'Mild', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.'}, {'id': 'OG002', 'title': 'Moderate', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.'}, {'id': 'OG003', 'title': 'Severe', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.9', 'spread': '43.1', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '25.9', 'groupId': 'OG001'}, {'value': '17.1', 'spread': '45.9', 'groupId': 'OG002'}, {'value': '17.7', 'spread': '67.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Terminal half-life of empagliflozin (empa) in plasma.\n\nThe standard deviation is actually the coefficient of variation.', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.'}, {'type': 'SECONDARY', 'title': 'Mean Residence Time (MRTpo)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.'}, {'id': 'OG001', 'title': 'Mild', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.'}, {'id': 'OG002', 'title': 'Moderate', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.'}, {'id': 'OG003', 'title': 'Severe', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'spread': '31.3', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '22.9', 'groupId': 'OG001'}, {'value': '15.5', 'spread': '37.2', 'groupId': 'OG002'}, {'value': '15.7', 'spread': '43.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Mean residence time of empagliflozin (empa) in the body.\n\nThe standard deviation is actually the coefficient of variation.', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.'}, {'type': 'SECONDARY', 'title': 'Apparent Clearance After Extravascular Administration (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.'}, {'id': 'OG001', 'title': 'Mild', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.'}, {'id': 'OG002', 'title': 'Moderate', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.'}, {'id': 'OG003', 'title': 'Severe', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.'}], 'classes': [{'categories': [{'measurements': [{'value': '179', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '150', 'spread': '34.4', 'groupId': 'OG001'}, {'value': '124', 'spread': '30.7', 'groupId': 'OG002'}, {'value': '103', 'spread': '23.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Apparent clearance of empagliflozin (empa) in the plasma after extravascular administration.\n\nThe standard deviation is actually the coefficient of variation.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution During the Terminal Phase (Vz/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.'}, {'id': 'OG001', 'title': 'Mild', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.'}, {'id': 'OG002', 'title': 'Moderate', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.'}, {'id': 'OG003', 'title': 'Severe', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.'}], 'classes': [{'categories': [{'measurements': [{'value': '298', 'spread': '39.5', 'groupId': 'OG000'}, {'value': '237', 'spread': '45.5', 'groupId': 'OG001'}, {'value': '173', 'spread': '35.0', 'groupId': 'OG002'}, {'value': '144', 'spread': '46.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Apparent volume of distribution during the terminal phase (λz).\n\nThe standard deviation is actually the coefficient of variation.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.'}, {'type': 'SECONDARY', 'title': 'Amount of Empagliflozin That is Eliminated in Urine (Ae0-96)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.'}, {'id': 'OG001', 'title': 'Mild', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.'}, {'id': 'OG002', 'title': 'Moderate', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.'}, {'id': 'OG003', 'title': 'Severe', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.'}], 'classes': [{'categories': [{'measurements': [{'value': '18400', 'spread': '26.5', 'groupId': 'OG000'}, {'value': '16900', 'spread': '20.6', 'groupId': 'OG001'}, {'value': '18500', 'spread': '35.0', 'groupId': 'OG002'}, {'value': '22500', 'spread': '23.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration', 'description': 'Amount of empagliflozin (empa) that is eliminated in urine over the time interval 0 to 96 hours.\n\nThe standard deviation is actually the coefficient of variation.', 'unitOfMeasure': 'nmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.'}, {'type': 'SECONDARY', 'title': 'Fraction of Empagliflozin Excreted Unchanged in Urine (fe0-96))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.'}, {'id': 'OG001', 'title': 'Mild', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.'}, {'id': 'OG002', 'title': 'Moderate', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.'}, {'id': 'OG003', 'title': 'Severe', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'spread': '26.5', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '20.6', 'groupId': 'OG001'}, {'value': '16.7', 'spread': '35.0', 'groupId': 'OG002'}, {'value': '20.3', 'spread': '23.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration', 'description': 'Fraction of empagliflozin (empa) excreted unchanged in urine from time points 0 to 96 hours.\n\nThe standard deviation is actually the coefficient of variation.', 'unitOfMeasure': 'percentage of empagliflozin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.'}, {'type': 'SECONDARY', 'title': 'Renal Clearance After Extravascular Administration (CL R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.'}, {'id': 'OG001', 'title': 'Mild', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.'}, {'id': 'OG002', 'title': 'Moderate', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.'}, {'id': 'OG003', 'title': 'Severe', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'spread': '30.3', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '48.0', 'groupId': 'OG001'}, {'value': '19.9', 'spread': '36.8', 'groupId': 'OG002'}, {'value': '21.3', 'spread': '37.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Renal clearance of empagliflozin (empa) in plasma after extravascular administration.\n\nThe standard deviation is actually the coefficient of variation.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.'}, {'type': 'SECONDARY', 'title': 'Urinary Glucose Excretion (UGE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.'}, {'id': 'OG001', 'title': 'Mild', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.'}, {'id': 'OG002', 'title': 'Moderate', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.'}, {'id': 'OG003', 'title': 'Severe', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.'}], 'classes': [{'categories': [{'measurements': [{'value': '86600', 'spread': '34.8', 'groupId': 'OG000'}, {'value': '81000', 'spread': '26.7', 'groupId': 'OG001'}, {'value': '79700', 'spread': '67.9', 'groupId': 'OG002'}, {'value': '79800', 'spread': '45.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration', 'description': 'Urinary glucose excretion, this endpoint was measured using Ae0-96.\n\nThe standard deviation is actually the coefficient of variation.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.'}, {'type': 'SECONDARY', 'title': 'Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.'}, {'id': 'OG001', 'title': 'Mild', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.'}, {'id': 'OG002', 'title': 'Moderate', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.'}, {'id': 'OG003', 'title': 'Severe', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.'}], 'classes': [{'title': 'Investigations: Electrocardiogram abnormal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Investigations: Nitrite urine present', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Drug administration until 4 days after drug administration or end-of-study visit, up to 19 days', 'description': 'Clinically relevant abnormalities for physical examination, vital signs, ECG, clinical laboratory tests and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events (AE).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS) included all subjects who had been dispensed study medication and were documented to have taken the investigational treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.'}, {'id': 'FG001', 'title': 'Mild', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.'}, {'id': 'FG002', 'title': 'Moderate', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.'}, {'id': 'FG003', 'title': 'Severe', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.'}, {'id': 'BG001', 'title': 'Mild', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.'}, {'id': 'BG002', 'title': 'Moderate', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.'}, {'id': 'BG003', 'title': 'Severe', 'description': 'Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '57.0', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '51.0', 'spread': '8.5', 'groupId': 'BG002'}, {'value': '53.9', 'spread': '9.6', 'groupId': 'BG003'}, {'value': '53.9', 'spread': '8.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-16', 'studyFirstSubmitDate': '2010-04-26', 'resultsFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2010-04-26', 'lastUpdatePostDateStruct': {'date': '2014-06-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-16', 'studyFirstPostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve 0 to Infinity (AUC0-∞)', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': "Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.\n\nThe standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."}, {'measure': 'Maximum Measured Concentration (Cmax)', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': "Maximum measured concentration of empagliflozin (empa) in plasma.\n\nThe standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.', 'description': 'Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.\n\nThe standard deviation is actually the coefficient of variation.'}, {'measure': 'Time From Dosing to Maximum Concentration (Tmax)', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.', 'description': 'Time from dosing to maximum concentration of empagliflozin (empa) in plasma.'}, {'measure': 'Terminal Rate Constant (λz)', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Terminal rate constant in plasma.\n\nThe standard deviation is actually the coefficient of variation.'}, {'measure': 'Terminal Half-Life (t1/2)', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Terminal half-life of empagliflozin (empa) in plasma.\n\nThe standard deviation is actually the coefficient of variation.'}, {'measure': 'Mean Residence Time (MRTpo)', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Mean residence time of empagliflozin (empa) in the body.\n\nThe standard deviation is actually the coefficient of variation.'}, {'measure': 'Apparent Clearance After Extravascular Administration (CL/F)', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Apparent clearance of empagliflozin (empa) in the plasma after extravascular administration.\n\nThe standard deviation is actually the coefficient of variation.'}, {'measure': 'Apparent Volume of Distribution During the Terminal Phase (Vz/F)', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Apparent volume of distribution during the terminal phase (λz).\n\nThe standard deviation is actually the coefficient of variation.'}, {'measure': 'Amount of Empagliflozin That is Eliminated in Urine (Ae0-96)', 'timeFrame': 'Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration', 'description': 'Amount of empagliflozin (empa) that is eliminated in urine over the time interval 0 to 96 hours.\n\nThe standard deviation is actually the coefficient of variation.'}, {'measure': 'Fraction of Empagliflozin Excreted Unchanged in Urine (fe0-96))', 'timeFrame': 'Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration', 'description': 'Fraction of empagliflozin (empa) excreted unchanged in urine from time points 0 to 96 hours.\n\nThe standard deviation is actually the coefficient of variation.'}, {'measure': 'Renal Clearance After Extravascular Administration (CL R)', 'timeFrame': 'Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Renal clearance of empagliflozin (empa) in plasma after extravascular administration.\n\nThe standard deviation is actually the coefficient of variation.'}, {'measure': 'Urinary Glucose Excretion (UGE)', 'timeFrame': 'Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration', 'description': 'Urinary glucose excretion, this endpoint was measured using Ae0-96.\n\nThe standard deviation is actually the coefficient of variation.'}, {'measure': 'Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator', 'timeFrame': 'Drug administration until 4 days after drug administration or end-of-study visit, up to 19 days', 'description': 'Clinically relevant abnormalities for physical examination, vital signs, ECG, clinical laboratory tests and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events (AE).'}]}, 'conditionsModule': {'conditions': ['Hepatic Insufficiency', 'Healthy']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nHealthy males and females. Hepatically impaired male and female subjects. Age: 18 - 75 years, BMI: 18-34 kg/m2 Creatinine clearance \\>80 mL/min (except for patients with severe hepatic impairment, see exclusion criteria.\n\nSigned and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.\n\nExclusion criteria:\n\nHealthy subjects (group 1)\n\n1. Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator.\n2. Relevant gastrointestinal tract surgery.\n3. Diseases of the central nervous system or psychiatric disorders or relevant neurological disorders.\n4. History of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure \\< 100 or \\> 160 mm Hg, diastolic blood pressure \\< 60 or \\> 100 mm Hg, pulse rate \\< 50 or \\> 100 1/min.\n5. Chronic or relevant acute infections.\n6. History of allergy/hypersensitivity.\n7. Intake of drugs with a long half-life (\\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial.\n8. Use within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation\n9. Participation in another trial with an investigational drug within 2 months after a multiple dose study or within 1 month after a single dose study.\n10. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day).\n11. Inability to refrain from smoking when confined to the study site on trial days.\n12. Alcohol abuse, drug abuse.\n13. Veins unsuited for iv puncture on either arm.\n14. Blood donation (more than 100 mL within four weeks prior to administration or during the trial).\n15. Excessive physical activities (within 48 hours prior to trial or during the trial).\n16. Any laboratory value outside the reference range that is of clinical relevance.\n17. Inability to comply with dietary regimen of study centre.\n18. Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.\n\n Hepatically impaired subjects (group 2-4):\n19. Decompensated gastrointestinal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.\n20. For patients with severe liver impairment (Child-Pugh C): Severe concurrent renal dysfunction (e.g., due to hepato-renal syndrome) and a creatinine clearance \\<40mL/min.\n21. Relevant gastrointestinal tract surgery.\n22. Diseases of the central nervous system or psychiatric disorders or relevant neurological disorders.\n23. Chronic or relevant acute infections.\n24. History of allergy/hypersensitivity.\n25. Intake of drugs with a long half-life (\\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial.\n26. Use within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation. Co-medication known to inhibit or induce P-glycoprotein (such as quinidine, cyclosporine, amiodarone) is not allowed. In dubious cases, a case by case decision will be made after consultation with the sponsor.\n27. Participation in another trial with an investigational drug within 2 months after a multiple dose study or within 1 month after a single dose study.\n28. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day).\n29. Inability to refrain from smoking when confined to the study site on trial days.\n30. Alcohol abuse, Drug abuse.\n31. Blood donation (more than 100 mL within four weeks prior to administration or during the trial).\n32. Excessive physical activities (within 48 hours prior to trial or during the trial).\n33. Clinically relevant laboratory abnormalities.\n34. Inability to comply with dietary regimen of study centre.\n35. Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions\n\n For female subjects of all groups:\n36. Pregnancy\n37. Positive pregnancy test\n38. No adequate contraception during the study and until 2 months after study completion.\n39. Lactation period.'}, 'identificationModule': {'nctId': 'NCT01111318', 'briefTitle': 'Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Pharmacokinetics, Safety and Tolerability of BI 10773 50 mg Single Dose in Male and Female Subjects With Different Degrees of Liver Impairment (Child-Pugh Classification A, B and C) as Compared to Male and Female Healthy Subjects (a Non-blinded, Parallel Group Study of Phase I)', 'orgStudyIdInfo': {'id': '1245.13'}, 'secondaryIdInfos': [{'id': '2009-017202-36', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 10773', 'description': '50 mg single dose', 'interventionNames': ['Drug: BI 10773']}], 'interventions': [{'name': 'BI 10773', 'type': 'DRUG', 'description': '2 tablets BI 10773 25 mg single dose', 'armGroupLabels': ['BI 10773']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Timișoara', 'country': 'Romania', 'facility': '1245.13.40001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}