Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-04 @ 11:51 PM
Study NCT ID:
NCT02002767
Status:
COMPLETED
Last Update Posted:
2020-11-16
First Post:
2013-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000604171', 'term': 'velpatasvir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose date plus 30 days', 'description': 'The Safety Analysis Set included participants who were enrolled and received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function received velpatasvir 100 mg administered orally with a light breakfast on Day 1.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received velpatasvir 100 mg administered orally with a light breakfast on Day 1.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vessel puncture site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetic (PK) Parameter of Velpatasvir: AUClast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function received velpatasvir 100 mg administered orally with a light breakfast on Day 1.'}, {'id': 'OG001', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received velpatasvir 100 mg administered orally with a light breakfast on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '5597.8', 'spread': '1749.18', 'groupId': 'OG000'}, {'value': '7971.7', 'spread': '2531.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean(GLSM) Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '149.05', 'ciLowerLimit': '116.62', 'ciUpperLimit': '190.49', 'groupDescription': 'A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1', 'description': 'AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all enrolled and treated participants who have evaluable PK profiles for velpatasvir.'}, {'type': 'PRIMARY', 'title': 'PK Parameter of Velpatasvir: AUCinf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function received velpatasvir 100 mg administered orally with a light breakfast on Day 1.'}, {'id': 'OG001', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received velpatasvir 100 mg administered orally with a light breakfast on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '5651.6', 'spread': '1763.12', 'groupId': 'OG000'}, {'value': '8108.3', 'spread': '2628.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GLSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '149.90', 'ciLowerLimit': '116.97', 'ciUpperLimit': '192.11', 'groupDescription': 'A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1', 'description': 'AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK Analysis Set were analyzed.'}, {'type': 'PRIMARY', 'title': 'PK Parameter of Velpatasvir: Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function received velpatasvir 100 mg administered orally with a light breakfast on Day 1.'}, {'id': 'OG001', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received velpatasvir 100 mg administered orally with a light breakfast on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '702.7', 'spread': '197.20', 'groupId': 'OG000'}, {'value': '732.4', 'spread': '176.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GLSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '110.85', 'ciLowerLimit': '90.76', 'ciUpperLimit': '135.38', 'groupDescription': 'A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1', 'description': 'Cmax is defined as the maximum observed plasma concentration of drug.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function received velpatasvir 100 mg administered orally with a light breakfast on Day 1.'}, {'id': 'OG001', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received velpatasvir 100 mg administered orally with a light breakfast on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date plus 30 days', 'description': 'Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function received velpatasvir 100 mg administered orally with a light breakfast on Day 1.'}, {'id': 'OG001', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received velpatasvir 100 mg administered orally with a light breakfast on Day 1.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date plus 30 days', 'description': 'A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug and within 30 days after last study drug administration. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage Protein Binding of Velpatasvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function received velpatasvir 100 mg administered orally with a light breakfast on Day 1.'}, {'id': 'OG001', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received velpatasvir 100 mg administered orally with a light breakfast on Day 1.'}], 'classes': [{'title': 'Free Protein Percentage', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Bound Protein Percentage', 'categories': [{'measurements': [{'value': '99.71', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '99.71', 'spread': '0.012', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 or 3 hours post-dose on Day 1', 'description': 'Mean velpatasvir protein binding (percentage free and percentage bound) was determined in all participants at 2 or 3 hours post-dose. Protein binding was assessed at Tmax whenever possible or at the time point closest to Tmax for each participant.', 'unitOfMeasure': 'percentage of plasma protein binding', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK Analysis Set were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function received velpatasvir 100 mg administered orally with a light breakfast on Day 1.'}, {'id': 'FG001', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received velpatasvir 100 mg administered orally with a light breakfast on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in United Stated and New Zealand. The first participant was screened on 16 December 2013. The last study visit occurred on 09 June 2014.', 'preAssignmentDetails': '46 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal Renal Function', 'description': 'Participants with normal renal function received velpatasvir 100 mg administered orally with a light breakfast on Day 1.'}, {'id': 'BG001', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received velpatasvir 100 mg administered orally with a light breakfast on Day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '71', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '68', 'spread': '4.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Analysis Set included participants who were enrolled and received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2014-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-20', 'studyFirstSubmitDate': '2013-12-02', 'resultsFirstSubmitDate': '2020-10-20', 'studyFirstSubmitQcDate': '2013-12-02', 'lastUpdatePostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-20', 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic (PK) Parameter of Velpatasvir: AUClast', 'timeFrame': 'Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1', 'description': 'AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.'}, {'measure': 'PK Parameter of Velpatasvir: AUCinf', 'timeFrame': 'Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1', 'description': 'AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.'}, {'measure': 'PK Parameter of Velpatasvir: Cmax', 'timeFrame': 'Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1', 'description': 'Cmax is defined as the maximum observed plasma concentration of drug.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Experiencing Treatment-Emergent Adverse Events', 'timeFrame': 'First dose date plus 30 days', 'description': 'Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.'}, {'measure': 'Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities', 'timeFrame': 'First dose date plus 30 days', 'description': 'A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug and within 30 days after last study drug administration. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening).'}, {'measure': 'Percentage Protein Binding of Velpatasvir', 'timeFrame': '2 or 3 hours post-dose on Day 1', 'description': 'Mean velpatasvir protein binding (percentage free and percentage bound) was determined in all participants at 2 or 3 hours post-dose. Protein binding was assessed at Tmax whenever possible or at the time point closest to Tmax for each participant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C Virus']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched healthy participants as a control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* General good health with stable chronic kidney disease in Severe Renal Impairment Group\n* Screening labs within defined thresholds\n* Creatinine clearance must be \\< 30 mL/min for Severe Renal Impairment group, and ≥ 90 mL/min for Normal Renal Function group\n\nKey Exclusion Criteria:\n\n* Females who are pregnant or nursing, or males who have a pregnant partner\n* Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV\n* History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with participant treatment and/or adherence to the protocol\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02002767', 'briefTitle': 'Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Renal Function and Severe Renal Impairment', 'orgStudyIdInfo': {'id': 'GS-US-281-1056'}, 'secondaryIdInfos': [{'id': '2013-004113-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants with renal impairment', 'description': 'Participants with severe renal impairment will receive a single dose of velpatasvir.', 'interventionNames': ['Drug: Velpatasvir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants with normal renal function', 'description': 'Participants with normal renal function will receive a single dose of velpatasvir.', 'interventionNames': ['Drug: Velpatasvir']}], 'interventions': [{'name': 'Velpatasvir', 'type': 'DRUG', 'otherNames': ['GS-5816'], 'description': 'Velpatasvir 100 mg (2 x 50 mg tablets) administered orally', 'armGroupLabels': ['Participants with normal renal function', 'Participants with renal impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '08011', 'city': 'Christchurch', 'country': 'New Zealand', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}