Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-31 @ 9:53 PM
Study NCT ID:
NCT04971928
Status:
COMPLETED
Last Update Posted:
2022-09-27
First Post:
2021-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2021-06-22', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)]', 'timeFrame': 'Up to Day 50 post-dose'}, {'measure': 'Maximum observed concentration (Cmax)', 'timeFrame': 'Up to Day 50 post-dose'}], 'secondaryOutcomes': [{'measure': 'AUC from time zero (pre-dose) to 24 hours [AUC(0-24)]', 'timeFrame': 'Up to 24 hours post-dose'}, {'measure': 'AUC from time zero (pre-dose) to 168 hours [AUC(0-168)]', 'timeFrame': 'Up to 168 hours post-dose'}, {'measure': 'Plasma concentration of GSK3228836 on Day 8', 'timeFrame': 'Day 8 post-dose'}, {'measure': 'Apparent terminal phase half-life (t1/2)', 'timeFrame': 'Up to Day 50 post-dose'}, {'measure': 'Apparent clearance (CL/F)', 'timeFrame': 'Up to Day 50 post-dose'}, {'measure': 'Time of occurrence of Cmax (Tmax)', 'timeFrame': 'Up to Day 50 post-dose'}, {'measure': 'Apparent terminal phase volume of distribution (Vz/F)', 'timeFrame': 'Up to Day 50 post-dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GSK3228836', 'Hepatitis B', 'Child-Pugh B (CP-B) cirrhosis', 'Child-Pugh A (CP-A) cirrhosis', 'Pharmacokinetics', 'B-Assured'], 'conditions': ['Hepatitis B']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, open-label, parallel-group study to evaluate the pharmacokinetics of GSK3228836 in participants with Child-Pugh B (CP-B) cirrhosis (moderate hepatic impairment), Child-Pugh A (CP-A) cirrhosis (mild hepatic impairment) and participants with normal hepatic function as healthy control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body weight \\>50 Kilogram (kg) and body mass index (BMI) within the range 19 to 40 Kilogram per square meters (kg/m2) (inclusive)\n* Capable of giving signed informed consent.\n* Child-Pugh B cirrhosis (moderate hepatic impairment; Part 1) or Child-Pugh A cirrhosis (mild hepatic impairment; Part 2) or a healthy control participant based on a medical evaluation including medical history, physical examination (PE), laboratory tests.\n\nExclusion Criteria:\n\n* Diagnosed or suspected hepatocellular carcinoma.\n* History of malignancy within the past 5 years except for cancers that are cured by surgical resection (e.g., skin cancer).\n* History of vasculitis or presence of symptoms and signs of potential vasculitis or history/presence of other diseases that may be associated with vasculitis condition.\n* Unstable cardiac function or high blood pressure that is not controlled (based on the investigator's discretion).\n* Any other medical condition which, in the judgment of the investigator and Medical Monitor, could jeopardize the integrity of the data derived from that participant or the safety of the participant.\n* Participants who have taken or are currently taking any therapies not allowed by the protocol.\n* A positive test for human immunodeficiency virus (HIV) antibody.\n* History of sensitivity to GSK3228836 or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation."}, 'identificationModule': {'nctId': 'NCT04971928', 'briefTitle': 'Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase 1, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics of GSK3228836 in Adults With Hepatic Impairment and Healthy Matched Control Participants (B-Assured)', 'orgStudyIdInfo': {'id': '205871'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants with Moderate (CP-B) hepatic impairment', 'interventionNames': ['Drug: GSK3228836']}, {'type': 'EXPERIMENTAL', 'label': 'Participants with Mild (CP-A) hepatic impairment', 'interventionNames': ['Drug: GSK3228836']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy participants', 'interventionNames': ['Drug: GSK3228836']}], 'interventions': [{'name': 'GSK3228836', 'type': 'DRUG', 'description': 'GSK3228836 will be administered', 'armGroupLabels': ['Healthy participants', 'Participants with Mild (CP-A) hepatic impairment', 'Participants with Moderate (CP-B) hepatic impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'http://clinicalstudydatarequest.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.', 'ipdSharing': 'YES', 'description': 'IPD for this study will be made available via the Clinical Study Data Request site.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}