Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-02-03 @ 1:57 PM
Study NCT ID:
NCT01580306
Status:
COMPLETED
Last Update Posted:
2015-07-31
First Post:
2012-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552340', 'term': 'faldaprevir'}]}}, '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 the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing)', 'description': 'Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.', 'eventGroups': [{'id': 'EG000', 'title': 'BI 201335 Relevant Treatment Dose (Normal Renal Function)', 'description': 'Capsule for oral administration\n\nestimated glomerular filtration rate \\>= 90 mL/min/1.73m2', 'otherNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BI 201335 Relevant Treatment Dose (Mild Renal Impairment)', 'description': 'Capsule for oral administration\n\nestimated glomerular filtration rate 60-89 mL/min/1.73m2', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BI 201335 Relevant Treatment Dose (Moderate Renal Impairment)', 'description': 'Capsule for oral administration\n\nestimated glomerular filtration rate 30-59 mL/min/1.73m2', 'otherNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'BI 201335 Relevant Treatment Dose (Severe Renal Impairment)', 'description': 'Capsule for oral administration\n\nestimated glomerular filtration rate 15-29 mL/min/1.73m2', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, '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 15.0'}, {'term': 'Blood pressure systolic increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, '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 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUC0-∞', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate \\>= 90 mL/min/1.73m2'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2'}], 'classes': [{'categories': [{'measurements': [{'value': '76500', 'spread': '95.7', 'groupId': 'OG000'}, {'value': '86900', 'spread': '89.8', 'groupId': 'OG001'}, {'value': '136000', 'spread': '67.2', 'groupId': 'OG002'}, {'value': '129000', 'spread': '98.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '113.57', 'ciLowerLimit': '41.58', 'ciUpperLimit': '310.17', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '93.2', 'estimateComment': 'the standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'relative bioavailability comparison mild : normal', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'investigation of relative bioavailability (no formal testing)'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '178.31', 'ciLowerLimit': '85.23', 'ciUpperLimit': '373.03', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '78.9', 'estimateComment': 'the standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'relative bioavailability comparison moderate : normal', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'investigation of relative bioavailability (no formal testing)'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '169.21', 'ciLowerLimit': '73.19', 'ciUpperLimit': '391.17', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '97.7', 'estimateComment': 'the standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'relative bioavailability comparison severe : normal', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'investigation of relative bioavailability (no formal testing)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration', 'description': 'area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity.\n\nIn this endpoint, the data of AUC0-∞ show inter-individual variabilities.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set: This subject set included all subjects in the treated set who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK, and who did not vomit at or before 2 times median tmax of unmetabolised faldaprevir.'}, {'type': 'PRIMARY', 'title': 'Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate \\>= 90 mL/min/1.73m2'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2'}], 'classes': [{'categories': [{'measurements': [{'value': '3810', 'spread': '80.7', 'groupId': 'OG000'}, {'value': '4080', 'spread': '144.0', 'groupId': 'OG001'}, {'value': '6680', 'spread': '63.2', 'groupId': 'OG002'}, {'value': '4600', 'spread': '135.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '107.22', 'ciLowerLimit': '35.16', 'ciUpperLimit': '327.01', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '107.7', 'estimateComment': 'the standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'relative bioavailability comparison mild : normal', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'investigation of relative bioavailability (no formal testing)'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '175.52', 'ciLowerLimit': '89.55', 'ciUpperLimit': '344.06', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '70.4', 'estimateComment': 'the standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'relative bioavailability comparison moderate : normal', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'investigation of relative bioavailability (no formal testing)'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '120.98', 'ciLowerLimit': '47.257', 'ciUpperLimit': '309.736', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '115', 'estimateComment': 'the standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'relative bioavailability comparison severe : normal', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'investigation of relative bioavailability (no formal testing)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration', 'description': 'maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'SECONDARY', 'title': 'Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate \\>= 90 mL/min/1.73m2'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2'}], 'classes': [{'title': 'Blood bilirubin increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'blood pressure systolic increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from drug administration up to 2 weeks', 'description': 'Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'treated set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Drug Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate \\>= 90 mL/min/1.73m2'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'drug administration until end-of-study examination (7 to 14 days after drug administration)', 'description': 'number of participants with investigator-defined drug related adverse events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'treated set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal Renal Function', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate \\>= 90 mL/min/1.73m2'}, {'id': 'FG001', 'title': 'Mild Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2'}, {'id': 'FG002', 'title': 'Moderate Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2'}, {'id': 'FG003', 'title': 'Severe Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'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': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal Renal Function', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate \\>= 90 mL/min/1.73m2'}, {'id': 'BG001', 'title': 'Mild Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2'}, {'id': 'BG002', 'title': 'Moderate Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2'}, {'id': 'BG003', 'title': 'Severe Renal Impairment', 'description': 'Capsule for oral administration (120 mg Faldaprevir)\n\nsubjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '58.8', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '67.1', 'spread': '7.5', 'groupId': 'BG002'}, {'value': '57.6', 'spread': '9.5', 'groupId': 'BG003'}, {'value': '61.4', 'spread': '8.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '21', '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': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-03', 'studyFirstSubmitDate': '2012-04-12', 'resultsFirstSubmitDate': '2015-07-03', 'studyFirstSubmitQcDate': '2012-04-18', 'lastUpdatePostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-03', 'studyFirstPostDateStruct': {'date': '2012-04-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-∞', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration', 'description': 'area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity.\n\nIn this endpoint, the data of AUC0-∞ show inter-individual variabilities.'}, {'measure': 'Cmax', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration', 'description': 'maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.'}], 'secondaryOutcomes': [{'measure': 'Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG', 'timeFrame': 'from drug administration up to 2 weeks', 'description': 'Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.'}, {'measure': 'Number of Participants With Drug Related Adverse Events', 'timeFrame': 'drug administration until end-of-study examination (7 to 14 days after drug administration)', 'description': 'number of participants with investigator-defined drug related adverse events.'}]}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to investigate the influence of mild, moderate and severe renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control group with normal renal function after single dose of BI 201335.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nMale and female healthy subjects with normal renal function and subjects with impaired renal function in relatively good health\n\nExclusion criteria:\n\nAny relevant deviation from healthy conditions for healthy volunteers or significant diseases other than renal impairment for the renal impaired subjects'}, 'identificationModule': {'nctId': 'NCT01580306', 'briefTitle': 'Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Pharmacokinetics, Safety and Tolerability of BI 201335 in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Monocentric, Open-label, Parallel-group, Phase I Trial', 'orgStudyIdInfo': {'id': '1220.58'}, 'secondaryIdInfos': [{'id': '2011-005442-35', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 201335 relevant treatment dose (A)', 'description': 'Capsule for oral administration', 'interventionNames': ['Drug: BI 201335']}, {'type': 'EXPERIMENTAL', 'label': 'BI 201335 relevant treatment dose (B)', 'description': 'Capsule for oral administration', 'interventionNames': ['Drug: BI 201335']}], 'interventions': [{'name': 'BI 201335', 'type': 'DRUG', 'description': 'Relevant treatment dose capsule (A) for oral administration', 'armGroupLabels': ['BI 201335 relevant treatment dose (A)']}, {'name': 'BI 201335', 'type': 'DRUG', 'description': 'Relevant treatment dose capsule (B) for oral administration', 'armGroupLabels': ['BI 201335 relevant treatment dose (B)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kiel', 'country': 'Germany', 'facility': '1220.58.1 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'}}}}