Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-01-11 @ 10:56 PM
Study NCT ID:
NCT03369002
Status:
COMPLETED
Last Update Posted:
2018-05-18
First Post:
2017-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713688', 'term': 'seladelpar'}, {'id': 'C572244', 'term': '(2-methyl-4-(5-methyl-2-(4-trifluoromethyl-phenyl)-2H-(1,2,3)triazol-4-ylmethylsulfanyl)phenoxy)acetic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-17', 'studyFirstSubmitDate': '2017-11-16', 'studyFirstSubmitQcDate': '2017-12-05', 'lastUpdatePostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': '5 days'}, {'measure': 'Time to reach maximum concentration (Tmax)', 'timeFrame': '5 days'}, {'measure': 'Area under of the curve (AUC0-t and AUC0-∞)', 'timeFrame': '5 days'}, {'measure': 'Elimination of half-life (t1/2)', 'timeFrame': '5 days'}, {'measure': 'Apparent terminal elimination rate constant (λz)', 'timeFrame': '5 days'}, {'measure': 'Total body clearance (CL/F)', 'timeFrame': '5 days'}, {'measure': 'Volume of distribution (Vz/F)', 'timeFrame': '5 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatic Impairment'], 'conditions': ['Hepatic Impairment']}, 'descriptionModule': {'briefSummary': 'This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have given written informed consent (signed and dated) and any authorizations required by local law.\n* Willing to be confined to CRU for the entire duration required by the protocol.\n* Male or female, between 18 and 80 years of age.\n* Healthy subject with normal liver function must be non-smoker and no use of other tobacco or nicotine-containing products. Subject with HI must be non-smoker, or smoke ≤10 cigarettes per day during the study.\n* Healthy subject must not be taking any prescribed or non-prescribed medications unless permitted. Subject with HI will be allowed to take their chronic medications unless excluded by the protocol.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Treatment with another investigational drug or device within 30 days prior to study drug administration.\n* Has donated or lost a significant volume of blood within 56 days or plasma within 7 days prior to Check-in day.\n* Inability to swallow medication.\n* Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1.\n* Positive test at Screening for HBsAg, hepatitis C virus (HCV), or HIV.'}, 'identificationModule': {'nctId': 'NCT03369002', 'briefTitle': 'Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 1, Open Label, Non-Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Seladelpar in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects With Normal Hepatic Function', 'orgStudyIdInfo': {'id': 'CB8025-11732'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal', 'description': 'Child-Pugh Score: N/A\n\nSubjects will receive a single 10 mg oral dose of seladelpar', 'interventionNames': ['Drug: seladelpar']}, {'type': 'EXPERIMENTAL', 'label': 'Mild Impairment', 'description': 'Child-Pugh Score: A (5 to 6 points)\n\nSubjects will receive a single 10 mg oral dose of seladelpar', 'interventionNames': ['Drug: seladelpar']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Impairment', 'description': 'Child-Pugh Score: B (7 to 9 points)\n\nSubjects will receive a single 10 mg oral dose of seladelpar', 'interventionNames': ['Drug: seladelpar']}, {'type': 'EXPERIMENTAL', 'label': 'Severe Impairment', 'description': 'Child-Pugh Score: C (10 to 15 points)\n\nSubjects will receive a single 10 mg oral dose of seladelpar', 'interventionNames': ['Drug: seladelpar']}], 'interventions': [{'name': 'seladelpar', 'type': 'DRUG', 'otherNames': ['MBX-8025'], 'description': 'Oral single dose 10 mg', 'armGroupLabels': ['Mild Impairment', 'Moderate Impairment', 'Normal', 'Severe Impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'DaVita Clinical Research', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'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}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vrg & Noccr', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}