Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-21 @ 1:55 AM
Study NCT ID:
NCT01957657
Status:
TERMINATED
Last Update Posted:
2016-04-11
First Post:
2013-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592437', 'term': 'deleobuvir'}, {'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': "Other - 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': 'The sponsor decided to stop the development of Hepatitis C treatments and terminated the trial prematurely on 27 Dec 2013. Due to the small sample size the pharmacokinetic endpoints were not determined.'}}, 'adverseEventsModule': {'timeFrame': 'From the first drug administration until day after end of trial examination, up to 18 days', 'eventGroups': [{'id': 'EG000', 'title': 'Deleobuvir + Faldaprevir, Mild Renal Impairment', 'description': 'Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.\n\nAdministration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.\n\nAll four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min.', 'otherNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deleobuvir + Faldaprevir, Mild Renal Impairment', 'description': 'Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.\n\nAdministration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.\n\nAll four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min.'}], 'timeFrame': 'Day 4', 'description': 'Blood sampling for Pharmacokinetic (PK) profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.', 'reportingStatus': 'POSTED', 'populationDescription': 'Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.'}, {'type': 'PRIMARY', 'title': 'Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) in Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deleobuvir + Faldaprevir, Mild Renal Impairment', 'description': 'Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.\n\nAdministration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.\n\nAll four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min.'}], 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.', 'reportingStatus': 'POSTED', 'populationDescription': 'Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined'}, {'type': 'SECONDARY', 'title': 'Number (%) of Subjects With Drug-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deleobuvir + Faldaprevir, Mild Renal Impairment', 'description': 'Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.\n\nAdministration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.\n\nAll four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first drug administration until last drug administration, up to 10 days', 'description': 'Number (percentage) of subjects with drug-related adverse events', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS) included all enrolled subjects, who had taken at least one dose of trial medication.'}, {'type': 'SECONDARY', 'title': 'AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deleobuvir + Faldaprevir, Mild Renal Impairment', 'description': 'Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.\n\nAdministration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.\n\nAll four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min.'}], 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.', 'reportingStatus': 'POSTED', 'populationDescription': 'Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.'}, {'type': 'SECONDARY', 'title': 'AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deleobuvir + Faldaprevir, Mild Renal Impairment', 'description': 'Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.\n\nAdministration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.\n\nAll four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min.'}], 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.', 'reportingStatus': 'POSTED', 'populationDescription': 'Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.'}, {'type': 'SECONDARY', 'title': 'AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deleobuvir + Faldaprevir, Mild Renal Impairment', 'description': 'Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.\n\nAdministration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.\n\nAll four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min.'}], 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.', 'reportingStatus': 'POSTED', 'populationDescription': 'Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.'}, {'type': 'SECONDARY', 'title': 'AUC 0-infinity (Area Under the Concentration-time Curve of Faldaprevir in Plasma Over the Time Interval From 0 Extrapolated to Infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deleobuvir + Faldaprevir, Mild Renal Impairment', 'description': 'Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.\n\nAdministration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.\n\nAll four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min.'}], 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.', 'reportingStatus': 'POSTED', 'populationDescription': 'Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.'}, {'type': 'SECONDARY', 'title': 'Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deleobuvir + Faldaprevir, Mild Renal Impairment', 'description': 'Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.\n\nAdministration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.\n\nAll four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min.'}], 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.', 'reportingStatus': 'POSTED', 'populationDescription': 'Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.'}, {'type': 'SECONDARY', 'title': 'Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deleobuvir + Faldaprevir, Mild Renal Impairment', 'description': 'Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.\n\nAdministration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.\n\nAll four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min.'}], 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.', 'reportingStatus': 'POSTED', 'populationDescription': 'Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.'}, {'type': 'SECONDARY', 'title': 'Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deleobuvir + Faldaprevir, Mild Renal Impairment', 'description': 'Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.\n\nAdministration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.\n\nAll four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min.'}], 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.', 'reportingStatus': 'POSTED', 'populationDescription': 'Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.'}, {'type': 'SECONDARY', 'title': 'Cmax (Maximum Measured Concentration of Faldaprevir in Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deleobuvir + Faldaprevir, Mild Renal Impairment', 'description': 'Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.\n\nAdministration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.\n\nAll four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min.'}], 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.', 'reportingStatus': 'POSTED', 'populationDescription': 'Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Deleobuvir + Faldaprevir, Mild Renal Impairment', 'description': 'Multiple doses of deleobuvir, immediate release tablet, plus faldaprevir, soft gelatin capsule, were planned to be administered over 4 days to patients with mild renal impairment.\n\nAdministration of 600 mg deleobuvir bid and 120 mg faldaprevir, qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.\n\nAll four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The patient groups with renal impairment were to be investigated consecutively starting with the mildly impaired, followed by the moderately impaired, and the severely impaired group. Normal renal function patients were to be investigated last. The trial was terminated after four patients were enrolled and completed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Deleobuvir + Faldaprevir, Mild Renal Impairment', 'description': 'Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.\n\nAdministration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.\n\nAll four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.8', 'spread': '10.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Treated Set, (TS) included all enrolled subjects, who had taken at least one dose of trial medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-16', 'studyFirstSubmitDate': '2013-10-01', 'resultsFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2013-10-01', 'lastUpdatePostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-16', 'studyFirstPostDateStruct': {'date': '2013-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)', 'timeFrame': 'Day 4', 'description': 'Blood sampling for Pharmacokinetic (PK) profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.'}, {'measure': 'Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) in Plasma)', 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.'}], 'secondaryOutcomes': [{'measure': 'Number (%) of Subjects With Drug-related Adverse Events', 'timeFrame': 'From the first drug administration until last drug administration, up to 10 days', 'description': 'Number (percentage) of subjects with drug-related adverse events'}, {'measure': 'AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)', 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.'}, {'measure': 'AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)', 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.'}, {'measure': 'AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)', 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.'}, {'measure': 'AUC 0-infinity (Area Under the Concentration-time Curve of Faldaprevir in Plasma Over the Time Interval From 0 Extrapolated to Infinity)', 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.'}, {'measure': 'Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma)', 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.'}, {'measure': 'Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma)', 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.'}, {'measure': 'Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma)', 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.'}, {'measure': 'Cmax (Maximum Measured Concentration of Faldaprevir in Plasma)', 'timeFrame': 'Day 4', 'description': 'Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.'}]}, 'conditionsModule': {'conditions': ['Renal Insufficiency']}, 'referencesModule': {'references': [{'pmid': '25348520', 'type': 'DERIVED', 'citation': 'Huang F, Moschetti V, Lang B, Halabi A, Petersen-Sylla M, Yong CL, Elgadi M. Pharmacokinetics, safety, and tolerability of faldaprevir in patients with renal impairment. Antimicrob Agents Chemother. 2015 Jan;59(1):251-7. doi: 10.1128/AAC.03359-14. Epub 2014 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the trial is to investigate the effect of different degrees of renal impairment on the pharmacokinetics and safety of the combination of BI 207127 and faldaprevir after 3 days of dosing (BI 207127 bid, faldaprevir qd) and a single dose of BI 207127 and faldaprevir on day 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy volunteers (males and females) or patients with impaired renal function (estimated glomerular filtration rate (eGFR) between 89 and 15) in relatively good health as determined by past medical history, physical examination, vital signs, ECG and laboratory assessments (aside from abnormalities specific for renal impairment)\n* Age from 18 to 79 years\n* Subjects must be able to understand and comply with study requirements\n\nExclusion criteria:\n\n* Any relevant deviation from healthy conditions for healthy volunteers\n* Subjects with significant diseases other than renal impairment will be excluded. A significant disease is defined as a disease which in the opinion of the investigator:\n\n * put the patient at risk because of participation in the study\n * may influence the results of the study\n * may influence the patients ability to participate in the study\n * is not in a stable condition\n* Diabetic or hypertensive patients can be entered in this trial if the disease is not significant according to these criteria'}, 'identificationModule': {'nctId': 'NCT01957657', 'briefTitle': 'Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Single Center, Open-label, Parallel-group, Phase I Trial', 'orgStudyIdInfo': {'id': '1241.32'}, 'secondaryIdInfos': [{'id': '2013-001075-21', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy volunteers group 1', 'description': 'Healthy volunteers with normal renal function', 'interventionNames': ['Drug: BI 207127', 'Drug: faldaprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Renal function group 2', 'description': 'Patients with mild renal impairment', 'interventionNames': ['Drug: BI 207127', 'Drug: faldaprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Renal function group 3', 'description': 'Patients with moderate renal impairment', 'interventionNames': ['Drug: BI 207127', 'Drug: faldaprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Renal function group 4', 'description': 'Patients with severe renal impairment', 'interventionNames': ['Drug: BI 207127', 'Drug: faldaprevir']}], 'interventions': [{'name': 'BI 207127', 'type': 'DRUG', 'description': 'oral administration', 'armGroupLabels': ['Renal function group 2']}, {'name': 'faldaprevir', 'type': 'DRUG', 'description': 'oral administration', 'armGroupLabels': ['Renal function group 2']}, {'name': 'BI 207127', 'type': 'DRUG', 'description': 'oral administration', 'armGroupLabels': ['Renal function group 4']}, {'name': 'BI 207127', 'type': 'DRUG', 'description': 'oral administration', 'armGroupLabels': ['Healthy volunteers group 1']}, {'name': 'BI 207127', 'type': 'DRUG', 'description': 'oral administration', 'armGroupLabels': ['Renal function group 3']}, {'name': 'faldaprevir', 'type': 'DRUG', 'description': 'oral administration', 'armGroupLabels': ['Renal function group 3']}, {'name': 'faldaprevir', 'type': 'DRUG', 'description': 'oral administration', 'armGroupLabels': ['Healthy volunteers group 1']}, {'name': 'faldaprevir', 'type': 'DRUG', 'description': 'oral administration', 'armGroupLabels': ['Renal function group 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kiel', 'country': 'Germany', 'facility': '1241.32.1 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'}}}}