Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-09 @ 4:05 AM
Study NCT ID:
NCT01830205
Status:
COMPLETED
Last Update Posted:
2015-11-16
First Post:
2013-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment
Sponsor:
Organization:
Raw JSON
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We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs', 'eventGroups': [{'id': 'EG000', 'title': 'Group-A', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mild/Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Mild/Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had eGFR \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Daclatasvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': 'Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG004', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \\< 15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '11215.264', 'spread': '40', 'groupId': 'OG000'}, {'value': '21261.199', 'spread': '62', 'groupId': 'OG001'}, {'value': '24789.951', 'spread': '35', 'groupId': 'OG002'}, {'value': '21946.450', 'spread': '39', 'groupId': 'OG003'}, {'value': '14257.489', 'spread': '25', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'AUC(INF) was estimated by summing the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and the extrapolated area, computed by the quotient of the last observable concentration and elimination rate constant. The pharmacokinetic (PK) analysis was based on Cockcroft-Gault (C-G) creatinine clearance (CLcr) grouping method: normal renal function, end stage renal disease (ESRD), moderate and severe renal impairment. Mild participants were counted as per their original allocation.', 'unitOfMeasure': 'nanograms*hours/milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on the C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.'}, {'type': 'SECONDARY', 'title': 'Unbound Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity Time (AUC(INF)u) of Daclatasvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': 'Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1'}, {'id': 'OG004', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.845', 'spread': '37', 'groupId': 'OG000'}, {'value': '128.157', 'spread': '41', 'groupId': 'OG001'}, {'value': '144.915', 'spread': '13', 'groupId': 'OG002'}, {'value': '139.576', 'spread': '43', 'groupId': 'OG003'}, {'value': '100.736', 'spread': '31', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'AUC(INF)u was calculated by multiplying the area under the plasma concentration-time curve from time zero extrapolated to infinite time by mean fraction of unbound drug from 1 hour post-dose time point.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Daclatasvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': 'Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG004', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1111.497', 'spread': '39', 'groupId': 'OG000'}, {'value': '1619.572', 'spread': '13', 'groupId': 'OG001'}, {'value': '1745.845', 'spread': '31', 'groupId': 'OG002'}, {'value': '1207.137', 'spread': '33', 'groupId': 'OG003'}, {'value': '1085.344', 'spread': '15', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analyzed for daclatasvir by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.'}, {'type': 'SECONDARY', 'title': 'Unbound Maximum Observed Plasma Concentrations of Daclatasvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': 'Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1'}, {'id': 'OG004', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.309', 'spread': '34', 'groupId': 'OG000'}, {'value': '9.762', 'spread': '14', 'groupId': 'OG001'}, {'value': '10.206', 'spread': '20', 'groupId': 'OG002'}, {'value': '7.677', 'spread': '33', 'groupId': 'OG003'}, {'value': '7.668', 'spread': '36', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'Unbound Maximum observed plasma concentrations (Cmaxu) was calculated by multiplying maximum observed plasma concentrations by mean fraction of unbound drug from 1 hour post-dose time point.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration [AUC(0-T)] of Daclatasvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': 'Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG004', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '11092.967', 'spread': '40', 'groupId': 'OG000'}, {'value': '20852.129', 'spread': '60', 'groupId': 'OG001'}, {'value': '24343.711', 'spread': '36', 'groupId': 'OG002'}, {'value': '21238.909', 'spread': '37', 'groupId': 'OG003'}, {'value': '13934.562', 'spread': '25', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'AUC(0-T) was calculated as the sum of linear trapezoids using non-compartmental analysis.', 'unitOfMeasure': 'ng*hour (h)/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Daclatasvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': 'Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG004', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.000', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.250', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '1.50'}, {'value': '1.000', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.500', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '1.250', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration-time data.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.'}, {'type': 'SECONDARY', 'title': 'Plasma Half-life (T-half) of Daclatasvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': 'Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG004', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.625', 'spread': '25', 'groupId': 'OG000'}, {'value': '15.661', 'spread': '31', 'groupId': 'OG001'}, {'value': '16.912', 'spread': '19', 'groupId': 'OG002'}, {'value': '20.224', 'spread': '24', 'groupId': 'OG003'}, {'value': '15.678', 'spread': '37', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'Terminal half-life was the time required for one half of the total amount of administered drug eliminated from the body.', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.'}, {'type': 'SECONDARY', 'title': 'Apparent Total Body Clearance (CLT/F) of Daclatasvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': 'Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG004', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.164', 'spread': '26', 'groupId': 'OG000'}, {'value': '47.034', 'spread': '43', 'groupId': 'OG001'}, {'value': '40.339', 'spread': '27', 'groupId': 'OG002'}, {'value': '45.565', 'spread': '31', 'groupId': 'OG003'}, {'value': '70.139', 'spread': '33', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'Apparent total body clearance was calculated by dividing the dose by area under the plasma concentration-time curve from time zero extrapolated to infinite time.', 'unitOfMeasure': 'milliliter/minute (mL/min)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.'}, {'type': 'SECONDARY', 'title': 'Unbound Apparent Clearance (CLU/F) of Daclatasvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': 'Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG004', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '11926.796', 'spread': '53', 'groupId': 'OG000'}, {'value': '7802.955', 'spread': '33', 'groupId': 'OG001'}, {'value': '6900.602', 'spread': '13', 'groupId': 'OG002'}, {'value': '7164.575', 'spread': '41', 'groupId': 'OG003'}, {'value': '9926.962', 'spread': '35', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'The CLU/F was calculated by dividing the apparent total body clearance by mean fraction of unbound drug from 1 hour post dose time point.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.'}, {'type': 'SECONDARY', 'title': 'Percent Urinary Recovery (%UR) of Daclatasvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': 'Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG004', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.007', 'spread': '36', 'groupId': 'OG000'}, {'value': '5.820', 'spread': '27', 'groupId': 'OG001'}, {'value': '3.530', 'spread': '40', 'groupId': 'OG002'}, {'value': '2.658', 'spread': '58', 'groupId': 'OG003'}, {'value': '0.199', 'spread': '131', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'The percentage of daclatasvir recovered in the urine was determined by using validated liquid chromatography-tandem mass spectrometry methods. The sum of the percentage of dose recovered in urine from all intervals was calculated to obtain the total percentage of urinary excretion.', 'unitOfMeasure': 'Percentage of daclatasvir recovered', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=3), moderate (n=5) and severe renal impairment (n=5). Mild participants (n=4) are also counted as per their original allocation.'}, {'type': 'SECONDARY', 'title': 'Renal Clearance (CLR) of Daclatasvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': 'Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG004', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.465', 'spread': '29', 'groupId': 'OG000'}, {'value': '2.737', 'spread': '28', 'groupId': 'OG001'}, {'value': '1.424', 'spread': '48', 'groupId': 'OG002'}, {'value': '1.165', 'spread': '37', 'groupId': 'OG003'}, {'value': '0.147', 'spread': '114', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'The CLR was calculated by dividing the total amount excreted in the urine from 0 to 96 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=3), moderate (n=5) and severe renal impairment (n=5). Mild participants (n=4) are also counted as per their original allocation.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vd/F) of Daclatasvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': 'Participants were re-randomized from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'OG004', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '105.157', 'spread': '37', 'groupId': 'OG000'}, {'value': '63.761', 'spread': '30', 'groupId': 'OG001'}, {'value': '59.054', 'spread': '36', 'groupId': 'OG002'}, {'value': '79.769', 'spread': '35', 'groupId': 'OG003'}, {'value': '95.186', 'spread': '37', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'The Vd/F was calculated by dividing the product of the dose and mean residence time by area under the plasma concentration-time curve from time zero extrapolated to infinite time.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events and Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function/Mild Renal Impairment', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'OG001', 'title': 'Mild/Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'OG002', 'title': 'Mild/Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'OG003', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had eGFR \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Discontinuations due to AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose up to Day 5 post last dose for AEs; up to 30 days post last dose for SAEs', 'description': 'Adverse event (AE) was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done in safety data set population, defined as all the participants who received the study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Laboratory Marked Abnormalities Reported as Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function/Mild Renal Impairment', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'OG001', 'title': 'Mild/Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'OG002', 'title': 'Mild/Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'OG003', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had eGFR \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 5 post dose', 'description': 'Significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done in safety population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Reported as Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function/Mild Renal Impairment', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'OG001', 'title': 'Mild/Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'OG002', 'title': 'Mild/Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'OG003', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had eGFR \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 5 post dose', 'description': 'The number of participants with clinically relevant changes in ECG which were considered as adverse events was determined.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done in safety data set population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Out-of-range Vital Signs Reported as Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function/Mild Renal Impairment', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'OG001', 'title': 'Mild/Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'OG002', 'title': 'Mild/Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'OG003', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had eGFR \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 5 post dose', 'description': 'The total number of participants with abnormal range vital signs which were considered as adverse events was determined.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done in safety data set population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal Renal Function/Mild Renal Impairment', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had estimated glomerular filtration rate (eGFR) 60-89 mL/min per 1.73 m\\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'FG001', 'title': 'Mild/Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'FG002', 'title': 'Mild/Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'FG003', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had eGFR \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 2 centers in United States of America.', 'preAssignmentDetails': 'A total of 58 participants were enrolled and 36 were treated with study drug. Remaining 22 were not treated (14 no longer met study criteria, 4 other reasons, 2 administrative reasons and 2 withdrew consent). Participants were grouped by Cockcroft-Gault creatine clearance method for primary analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal Renal Function/Mild Renal Impairment', 'description': 'Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \\>=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'BG001', 'title': 'Mild/Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'BG002', 'title': 'Mild/Severe Renal Impairment', 'description': 'Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.'}, {'id': 'BG003', 'title': 'End Stage Renal Disease', 'description': 'Participants with end stage renal disease and had eGFR \\<15 mL/ min per 1.73 m\\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.6', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '62.0', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '66.3', 'spread': '9.9', 'groupId': 'BG002'}, {'value': '49.0', 'spread': '11.7', 'groupId': 'BG003'}, {'value': '53.9', 'spread': '12.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-13', 'studyFirstSubmitDate': '2013-04-10', 'resultsFirstSubmitDate': '2015-08-19', 'studyFirstSubmitQcDate': '2013-04-10', 'lastUpdatePostDateStruct': {'date': '2015-11-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-13', 'studyFirstPostDateStruct': {'date': '2013-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Daclatasvir', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'AUC(INF) was estimated by summing the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and the extrapolated area, computed by the quotient of the last observable concentration and elimination rate constant. The pharmacokinetic (PK) analysis was based on Cockcroft-Gault (C-G) creatinine clearance (CLcr) grouping method: normal renal function, end stage renal disease (ESRD), moderate and severe renal impairment. Mild participants were counted as per their original allocation.'}], 'secondaryOutcomes': [{'measure': 'Unbound Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity Time (AUC(INF)u) of Daclatasvir', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'AUC(INF)u was calculated by multiplying the area under the plasma concentration-time curve from time zero extrapolated to infinite time by mean fraction of unbound drug from 1 hour post-dose time point.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Daclatasvir', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analyzed for daclatasvir by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay.'}, {'measure': 'Unbound Maximum Observed Plasma Concentrations of Daclatasvir', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'Unbound Maximum observed plasma concentrations (Cmaxu) was calculated by multiplying maximum observed plasma concentrations by mean fraction of unbound drug from 1 hour post-dose time point.'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration [AUC(0-T)] of Daclatasvir', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'AUC(0-T) was calculated as the sum of linear trapezoids using non-compartmental analysis.'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Daclatasvir', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration-time data.'}, {'measure': 'Plasma Half-life (T-half) of Daclatasvir', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'Terminal half-life was the time required for one half of the total amount of administered drug eliminated from the body.'}, {'measure': 'Apparent Total Body Clearance (CLT/F) of Daclatasvir', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'Apparent total body clearance was calculated by dividing the dose by area under the plasma concentration-time curve from time zero extrapolated to infinite time.'}, {'measure': 'Unbound Apparent Clearance (CLU/F) of Daclatasvir', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'The CLU/F was calculated by dividing the apparent total body clearance by mean fraction of unbound drug from 1 hour post dose time point.'}, {'measure': 'Percent Urinary Recovery (%UR) of Daclatasvir', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'The percentage of daclatasvir recovered in the urine was determined by using validated liquid chromatography-tandem mass spectrometry methods. The sum of the percentage of dose recovered in urine from all intervals was calculated to obtain the total percentage of urinary excretion.'}, {'measure': 'Renal Clearance (CLR) of Daclatasvir', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'The CLR was calculated by dividing the total amount excreted in the urine from 0 to 96 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time.'}, {'measure': 'Apparent Volume of Distribution (Vd/F) of Daclatasvir', 'timeFrame': 'Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose', 'description': 'The Vd/F was calculated by dividing the product of the dose and mean residence time by area under the plasma concentration-time curve from time zero extrapolated to infinite time.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events and Who Died', 'timeFrame': 'First dose up to Day 5 post last dose for AEs; up to 30 days post last dose for SAEs', 'description': 'Adverse event (AE) was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Marked Abnormalities Reported as Adverse Events', 'timeFrame': 'Baseline up to Day 5 post dose', 'description': 'Significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator.'}, {'measure': 'Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Reported as Adverse Events', 'timeFrame': 'Baseline up to Day 5 post dose', 'description': 'The number of participants with clinically relevant changes in ECG which were considered as adverse events was determined.'}, {'measure': 'Number of Participants With Out-of-range Vital Signs Reported as Adverse Events', 'timeFrame': 'Baseline up to Day 5 post dose', 'description': 'The total number of participants with abnormal range vital signs which were considered as adverse events was determined.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '25654812', 'type': 'DERIVED', 'citation': 'Garimella T, Wang R, Luo WL, Hwang C, Sherman D, Kandoussi H, Marbury TC, Alcorn H, Bertz R, Bifano M. Single-dose pharmacokinetics and safety of daclatasvir in subjects with renal function impairment. Antivir Ther. 2015;20(5):535-43. doi: 10.3851/IMP2941. Epub 2015 Feb 5.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of renal function impairment on the single dose pharmacokinetics of Daclatasvir.', 'detailedDescription': 'Treatment, Parallel Assignment, Open Label, Non-Randomized, Single Dose Adaptive Design, Pharmacokinetics Study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Meet renal function criteria in one of four categories\n\nExclusion Criteria:\n\n\\- Unstable or uncontrolled medical conditions'}, 'identificationModule': {'nctId': 'NCT01830205', 'briefTitle': 'Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Single Dose Pharmacokinetics and Safety of Daclatasvir in Subjects With Renal Function Impairment', 'orgStudyIdInfo': {'id': 'AI444-063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (Normal renal function): Daclatasvir', 'description': 'Daclatasvir 60 mg tablet by mouth single dose on Day 1', 'interventionNames': ['Drug: Daclatasvir']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (End Stage Renal Disease): Daclatasvir', 'description': 'Daclatasvir 60 mg tablet by mouth single dose on Day 1', 'interventionNames': ['Drug: Daclatasvir']}, {'type': 'EXPERIMENTAL', 'label': 'Group C (Moderate renal impairment): Daclatasvir', 'description': 'Daclatasvir 60 mg tablet by mouth single dose on Day 1', 'interventionNames': ['Drug: Daclatasvir']}, {'type': 'EXPERIMENTAL', 'label': 'Group D (Severe renal impairment): Daclatasvir', 'description': 'Daclatasvir 60 mg tablet by mouth single dose on Day 1', 'interventionNames': ['Drug: Daclatasvir']}], 'interventions': [{'name': 'Daclatasvir', 'type': 'DRUG', 'otherNames': ['BMS-790052'], 'armGroupLabels': ['Group A (Normal renal function): Daclatasvir', 'Group B (End Stage Renal Disease): Daclatasvir', 'Group C (Moderate renal impairment): Daclatasvir', 'Group D (Severe renal impairment): Daclatasvir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Davita Clinical Research', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}