Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-03-26 @ 9:37 PM
Study NCT ID:
NCT03681457
Status:
COMPLETED
Last Update Posted:
2020-12-14
First Post:
2018-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630573', 'term': 'tropifexor'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2018-09-11', 'studyFirstSubmitQcDate': '2018-09-21', 'lastUpdatePostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Up to 8 days', 'description': 'The maximum (peak) observed drug concentration after single dose administration (mass x volume-1)'}, {'measure': 'Tmax', 'timeFrame': 'Up to 8 days', 'description': 'Time to reach the maximum (peak) plasma drug concentration after single dose administration (time)'}, {'measure': 'AUClast', 'timeFrame': 'Up to 8 days', 'description': 'The area under the concentration-time curve from time zero to the time of the last quantifiable concentration sampling time (mass x time x volume-1)'}, {'measure': 'AUCinf', 'timeFrame': 'Up to 8 days', 'description': 'The area under the concentration-time curve from time zero to infinity (mass x time x volume-1)'}, {'measure': 'T1/2', 'timeFrame': 'Up to 8 days', 'description': 'The elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve'}, {'measure': 'CL/F', 'timeFrame': 'Up to 8 days', 'description': 'The apparent total body clearance of the drug from plasma (volume x time-1)'}, {'measure': 'Vz/F', 'timeFrame': 'Up to 8 days', 'description': 'The apparent volume of distribution during the terminal phase'}], 'secondaryOutcomes': [{'measure': 'fu', 'timeFrame': 'Day 1', 'description': 'Fraction of analyte unbound calculated in-vitro'}, {'measure': 'Cmax,u', 'timeFrame': 'Day 1', 'description': 'The maximum (peak) observed plasma drug concentration after single dose administration (Cmax) of unbound drug (mass x time x volume-1), calculated as Cmax\\*fu'}, {'measure': 'AUClast,u', 'timeFrame': 'Day 1', 'description': 'The area under the concentration-time curve from time zero to the last quantifiable concentration sampling time of unbound drug (mass x time x volume-1), calculated as AUClast\\*fu'}, {'measure': 'AUCinf,u', 'timeFrame': 'Day 1', 'description': 'The area under the concentration-time curve from time zero to infinity of unbound drug (mass x time x volume-1), calculated as AUCinf\\*fu'}, {'measure': 'CL/F,u', 'timeFrame': 'Day 1', 'description': 'The apparent total body clearance of drug from the plasma of unbound drug (volume x time-1), calculated as CL/F/fu'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LJN452', 'tropifexor', 'PK', 'safety', 'healthy subjects', 'hepatically impaired', 'Nonalcoholic Steatohepatitis', 'Nonalcoholic Fatty Liver Disease', 'NAFLD'], 'conditions': ['Non-alcoholic Fatty Liver Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17722', 'label': 'Results for CCLJN452A2109 can be found on the Novartis Clinical Trial Results Website'}, {'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=555', 'label': 'A Plain Language Trial Summary is available on novartisclinicaltrials.com'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with hepatic impairment. The results of this study will support treatment and dosing decisions for patients with varying degrees of hepatic impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'All subjects:\n\nInclusions Criteria:\n\n* Subjects must weight at least 50 kg, with a BMI within the range of 18 to 38 kg/m2\n* Must be willing to remain in the clinical research unit as required by the protocol\n\nExclusion Criteria:\n\n* Use of other study drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations\n* History of hypersensitivity to the study treatment or to drugs of similar chemical classes\n* Pregnant or nursing women\n* Women of child-bearing potential\n\nHealthy Volunteers:\n\nInclusion Criteria:\n\n\\- In good health as determined by past medical history, physical examination, ECG, laboratory tests, and urinalysis at Screening.\n\nExclusion Criteria:\n\n* Liver disease or liver injury\n* Chronic infection with Hepatitis B or Hepatitis C\n* History or presence of impaired renal function\n\nHepatically Impaired Subjects:\n\nInclusion Criteria:\n\n\\- Hepatic impairment as defined by the Child-Pugh classification for severity of liver disease\n\nExclusion Criteria:\n\n* Severe complications of liver disease within the preceding 3 months\n* Emergency room visit or hospitalization due to liver disease within the preceding 3 months for mildly and moderately hepatically impaired subjects, and within the preceding 1 month for severely hepatically impaired subjects\n* Subject has received liver transplant at any time in the past and is on immunosuppressant therapy\n* Acute Hepatitis B or Hepatitis C infection\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03681457', 'briefTitle': 'Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase 1, Open-label, Single-dose, Multi-center, Parallel Group Study to Evaluate the Pharmacokinetics of Tropifexor (LJN452) in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Control Subjects', 'orgStudyIdInfo': {'id': 'CLJN452A2109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1 - Normal Hepatic Function', 'description': 'Normal hepatic function - Control - control group', 'interventionNames': ['Drug: LJN452']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 - Mild Hepatic Impairment', 'description': 'Mild hepatic impairment - Child-Pugh A (Score 5-6)', 'interventionNames': ['Drug: LJN452']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 - Moderate Hepatic Impairment', 'description': 'Moderate hepatic impairment - Child-Pugh B (Score 7-9)', 'interventionNames': ['Drug: LJN452']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4 - Severe Hepatic Impairment', 'description': 'Severe hepatic impairment - Child-Pugh C (score 10-15)', 'interventionNames': ['Drug: LJN452']}], 'interventions': [{'name': 'LJN452', 'type': 'DRUG', 'description': 'Dose A single dose', 'armGroupLabels': ['Group 1 - Normal Hepatic Function', 'Group 2 - Mild Hepatic Impairment', 'Group 3 - Moderate Hepatic Impairment', 'Group 4 - Severe Hepatic Impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}