Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-03 @ 12:16 AM
Study NCT ID:
NCT02096718
Status:
COMPLETED
Last Update Posted:
2016-01-14
First Post:
2014-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Afatinib in Subjects With Kidney Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, '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}, 'limitationsAndCaveats': {'description': 'Two healthy volunteers were matched to 2 different groups i.e. subjects with moderate renal impairment and subjects with severe renal impairment.'}}, 'adverseEventsModule': {'timeFrame': 'From first administration of trial medication until the end of trial examination, up to 17 days', 'description': 'The residual effect period (REP) for afatinib in subjects with renal impairment (that is, the time period in which measurable drug levels were still likely to be present) was 17 days. Therefore, all AEs reported within 17 days of afatinib administration were to be considered as occurring on treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Afatinib in Healthy Subjects', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects', 'otherNumAtRisk': 14, 'otherNumAffected': 4, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Afatinib in Moderate Renal Impairment', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water', 'otherNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Afatinib in Severe Renal Impairment', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUC 0-tz of Afatinib (BIBW 2992)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib in Moderate Renal Impairment', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water'}, {'id': 'OG001', 'title': 'Afatinib in Severe Renal Impairment', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water'}, {'id': 'OG002', 'title': 'Afatinib in Healthy Subjects Matched to Moderate', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate renal impaired subjects'}, {'id': 'OG003', 'title': 'Afatinib in Healthy Subjects Matched to Severe', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to severe renal impaired subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '948', 'spread': '32.9', 'groupId': 'OG000'}, {'value': '952', 'spread': '31.3', 'groupId': 'OG001'}, {'value': '776', 'spread': '22.9', 'groupId': 'OG002'}, {'value': '634', 'spread': '50.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of gmeans', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '122.23', 'ciLowerLimit': '95.743', 'ciUpperLimit': '156.045', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '28.3', 'estimateComment': 'Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).', 'groupDescription': 'The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of gmeans', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '149.97', 'ciLowerLimit': '105.266', 'ciUpperLimit': '213.671', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '41.9', 'estimateComment': 'Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).', 'groupDescription': 'The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic set (PKS): included all patients in the treated set who provided evaluable data for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.'}, {'type': 'PRIMARY', 'title': 'Cmax of Afatinib (BIBW 2992)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib in Moderate Renal Impairment', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water'}, {'id': 'OG001', 'title': 'Afatinib in Severe Renal Impairment', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water'}, {'id': 'OG002', 'title': 'Afatinib in Healthy Subjects Matched to Moderate', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate renal impaired subjects'}, {'id': 'OG003', 'title': 'Afatinib in Healthy Subjects Matched to Severe', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to severe renal impaired subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'spread': '44.0', 'groupId': 'OG000'}, {'value': '28.2', 'spread': '24.5', 'groupId': 'OG001'}, {'value': '28.3', 'spread': '32.2', 'groupId': 'OG002'}, {'value': '23.2', 'spread': '42.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of gmeans', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.16', 'ciLowerLimit': '72.931', 'ciUpperLimit': '140.309', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '38.5', 'estimateComment': 'Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).', 'groupDescription': 'The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of gmeans', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '121.71', 'ciLowerLimit': '90.790', 'ciUpperLimit': '163.162', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '34.2', 'estimateComment': 'Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).', 'groupDescription': 'The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration', 'description': 'Maximum measured concentration of the analyte in plasma', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic set (PKS): included all patients in the treated set who provided evaluable data for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.'}, {'type': 'SECONDARY', 'title': 'AUC 0-inf of Afatinib (BIBW 2992)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib in Moderate Renal Impairment', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water'}, {'id': 'OG001', 'title': 'Afatinib in Severe Renal Impairment', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water'}, {'id': 'OG002', 'title': 'Afatinib in Healthy Subjects Matched to Moderate', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate renal impaired subjects'}, {'id': 'OG003', 'title': 'Afatinib in Healthy Subjects Matched to Severe', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to severe renal impaired subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '976', 'spread': '32.5', 'groupId': 'OG000'}, {'value': '980', 'spread': '31.9', 'groupId': 'OG001'}, {'value': '797', 'spread': '22.7', 'groupId': 'OG002'}, {'value': '653', 'spread': '49.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of gmeans', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '122.44', 'ciLowerLimit': '96.141', 'ciUpperLimit': '155.928', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '28.0', 'estimateComment': 'Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).', 'groupDescription': 'The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of gmeans', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '150.08', 'ciLowerLimit': '105.626', 'ciUpperLimit': '213.250', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '41.5', 'estimateComment': 'Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).', 'groupDescription': 'The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic set (PKS): included all patients in the treated set who provided evaluable data for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Afatinib in Moderate Renal Impairment', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water'}, {'id': 'FG001', 'title': 'Afatinib in Severe Renal Impairment', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water'}, {'id': 'FG002', 'title': 'Afatinib in Healthy Subjects', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '30 patients were entered, treated and analyzed.', 'preAssignmentDetails': 'This was a non-randomised, non-controlled, open-label, single-dose trial with matched group design. Group 1 contained subjects with moderate renal impairment, Group 2 subjects with severe renal impairment, and Group 3 subjects with normal renal function; groups were dosed sequentially.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Afatinib in Moderate Renal Impairment', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water'}, {'id': 'BG001', 'title': 'Afatinib in Severe Renal Impairment', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water'}, {'id': 'BG002', 'title': 'Afatinib in Healthy Subjects', 'description': 'Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.6', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '61.0', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '11.4', 'groupId': 'BG002'}, {'value': '63.6', 'spread': '11.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '(Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. All 30 subjects were included in the treated set (TS)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-09', 'studyFirstSubmitDate': '2014-03-24', 'resultsFirstSubmitDate': '2015-12-09', 'studyFirstSubmitQcDate': '2014-03-24', 'lastUpdatePostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-09', 'studyFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC 0-tz of Afatinib (BIBW 2992)', 'timeFrame': 'PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point'}, {'measure': 'Cmax of Afatinib (BIBW 2992)', 'timeFrame': 'PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration', 'description': 'Maximum measured concentration of the analyte in plasma'}], 'secondaryOutcomes': [{'measure': 'AUC 0-inf of Afatinib (BIBW 2992)', 'timeFrame': 'PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity'}]}, 'conditionsModule': {'conditions': ['Renal Insufficiency']}, 'referencesModule': {'references': [{'pmid': '27436099', 'type': 'DERIVED', 'citation': 'Wiebe S, Schnell D, Kulzer R, Gansser D, Weber A, Wallenstein G, Halabi A, Conrad A, Wind S. Influence of Renal Impairment on the Pharmacokinetics of Afatinib: An Open-Label, Single-Dose Study. Eur J Drug Metab Pharmacokinet. 2017 Jun;42(3):461-469. doi: 10.1007/s13318-016-0359-9.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the current study is to investigate the influence of moderate to severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in comparison to a control group with normal renal function.\n\nThe assessment of safety and tolerability will be an additional objective of this trial and will be evaluated by descriptive statistics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Despite renal impairment (group 1 and 2) healthy males or females according to the investigators assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests.\n* Glomerular filtration rate (GFR), estimated according to:\n\n \\-- MDRD (Modification of Diet in Renal Disease)-formula:\n * eGFR (estimated Glomerular Filtration Rate) \\[ml/min/1.73m²\\]= 175 x Serum Creatinine-1.154 x age-0.203 (if male)\n * eGFR\\[ml/min/1.73m²\\]= 175 x Serum Creatinine-1.154 x age-0.203 x 0.742 (if female)\n * 30 to 59 mL/min for moderate renal impairment group 1\n * 15 to 29 mL/min for severe renal impairment group 2\n * = 90 mL/min for healthy volunteers group 3\n* Age =18 and =79 years\n\nExclusion criteria:\n\n* Any finding of the medical examination (including Blood Pressure (BP), Pulse Rate (PR) and Electrocardiogram (ECG)) deviating from normal and of clinical relevance, e.g. repeated measurement of systolic blood pressure \\< 90 mmHg (millimeter of mercury) or \\> 140 mmHg, diastolic blood pressure \\< 50 mmHg or \\> 90 mmHg, repeated measurement of pulse rate \\< 45 bpm (beats per minute) or \\> 90 bpm.\n* Any evidence of a clinically relevant concomitant disease.\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, dermatological or hormonal disorders.\n* Relevant gastrointestinal tract surgery (except appendectomy).\n* Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or neurological disorders.\n* History of photosensitivity or recurrent rash.\n* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.'}, 'identificationModule': {'nctId': 'NCT02096718', 'briefTitle': 'Afatinib in Subjects With Kidney Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Pharmacokinetics, Safety and Tolerability After Single Dose Administration of Afatinib in Moderate and Severe Renal Impairment in Comparison to Subjects With Normal Renal Function (a Mono-centric, Open-label Study in Matched-group Design)', 'orgStudyIdInfo': {'id': '1200.216'}, 'secondaryIdInfos': [{'id': '2013-004825-98', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Afatinib in moderate renal impaired', 'description': 'Single Dose Afatinib in moderate renal impaired subjects', 'interventionNames': ['Drug: Afatinib moderate renally impaired']}, {'type': 'EXPERIMENTAL', 'label': 'Afatinib in severe renal impaired', 'description': 'Single Dose Afatinib in severe renal impaired subjects', 'interventionNames': ['Drug: Afatinib severe renally impaired']}, {'type': 'OTHER', 'label': 'Afatinib in healthy subjects', 'description': 'Single Dose Afatinib in healthy subjects matched by gender, race, age and BMI to moderate and severe renal impaired subjects', 'interventionNames': ['Drug: Afatinib healthy']}], 'interventions': [{'name': 'Afatinib healthy', 'type': 'DRUG', 'armGroupLabels': ['Afatinib in healthy subjects']}, {'name': 'Afatinib severe renally impaired', 'type': 'DRUG', 'armGroupLabels': ['Afatinib in severe renal impaired']}, {'name': 'Afatinib moderate renally impaired', 'type': 'DRUG', 'armGroupLabels': ['Afatinib in moderate renal impaired']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kiel', 'country': 'Germany', 'facility': '1200.216.1 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}