Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT04814602
Status:
COMPLETED
Last Update Posted:
2022-03-15
First Post:
2021-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single-dose PK Assessment of Oral Proglumide in Those With Hepatic Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-10-12', 'releaseDate': '2022-04-04'}, {'resetDate': '2023-12-04', 'releaseDate': '2023-02-22'}, {'resetDate': '2024-05-24', 'releaseDate': '2023-12-10'}, {'releaseDate': '2025-12-23'}], 'estimatedResultsFirstSubmitDate': '2022-04-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011377', 'term': 'Proglumide'}], 'ancestors': [{'id': 'D005973', 'term': 'Glutamine'}, {'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'open labeled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-14', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-22', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proglumide blood levels in hepatic impaired subjects', 'timeFrame': '24 hours', 'description': 'Proglumide levels in ng/ml in cirrhosis subjects compared to healthy controls'}], 'secondaryOutcomes': [{'measure': 'Urinary excretion of proglumide', 'timeFrame': '24 hours', 'description': 'Measurement of proglumide in urine after single does ingestion in cirrhosis compared to healthy controls'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cirrhosis, Liver']}, 'descriptionModule': {'briefSummary': 'Proglumide is an oral cholecystokinin (CCK) receptor antagonist that has been shown in non-clinical studies to reverse hepatic fibrosis and decrease the incidence of hepatocellular carcinoma (HCC). Because of these potential beneficial properties, proglumide may be useful in decreasing the fibrosis and risk for HCC in those with cirrhosis. Although proglumide is safe in those with normal hepatic function, the pharmacokinetics have not been established in those that are hepatic impaired. The purpose of this study is to analyze proglumide blood levels and excretion in subjects with cirrhosis compared to health controls.', 'detailedDescription': 'The purpose of this study is to measure blood levels of proglumide after a single oral dose (400 mg) over a period of time and compare the blood levels to those with normal hepatic function (N=4) to determine if there is delayed metabolism and clearance of proglumide in those with hepatic impairment (HI) (N=8). Eligible subjects will provide a baseline blood and urine sample prior to ingesting proglumide 400 mg po. Blood will be collected from an intravenous catheter after ingestion at the following intervals: 1 hr, 3 hrs, 5 hrs, 7 hrs and 24 hr (± 4-5 hours). After 3 hrs and 5 hrs subjects will provide a urine sample. Samples will be analyzed by Mass Spectometry. Proglumide blood and urine levels in ng/ml will be plotted over time and the Cmax (peak plasma concentration), Tmax (time to reach Cmax) and T1/2 (elimination half time) calculated for each subject and compared to that of 4 healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cirrhosis previously confirmed by one of the following: Liver biopsy, FibroScan, FibroSure, MR-Elastography, or nodular liver on radiographic imaging like CT or MRI. Child-Pugh classification A (N=4) and Child-Pugh classification B (N=4)\n\nExclusion Criteria:\n\n* Those that are Child-Pugh classification C cirrhosis\n* gastrointestinal bleeding from esophageal varices within 6 months\n* Chronic kidney disease with Estimated glomerular filtration rate (eGFR of \\< 90 mL/min/1.73m2)\n* hepatic encephalopathy\n* those that have had an organ transplant\n* active hepatitis C, active hepatitis B, and those with HIV disease\n\n * Adults unable to consent\n * Individuals who are not yet adults (infants, children, teenagers)\n * Pregnant women\n * Prisoners'}, 'identificationModule': {'nctId': 'NCT04814602', 'acronym': 'HIPK', 'briefTitle': 'Single-dose PK Assessment of Oral Proglumide in Those With Hepatic Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'Single-dose Pharmacokinetic (PK) Assessment of Oral Proglumide in Those With Hepatic Impairment', 'orgStudyIdInfo': {'id': '3464'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Healthy controls Proglumide 400 mg given once by mouth', 'interventionNames': ['Drug: Proglumide']}, {'type': 'EXPERIMENTAL', 'label': 'Hepatic Impaired', 'description': 'Cirrhosis Child-Pugh A and B Proglumide 400 mg given once by mouth', 'interventionNames': ['Drug: Proglumide']}], 'interventions': [{'name': 'Proglumide', 'type': 'DRUG', 'otherNames': ['Milid'], 'description': 'CCK receptor antagonist', 'armGroupLabels': ['Control', 'Hepatic Impaired']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Jill P Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgetown University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Will be published and placed on clinicaltrials website'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-04-04', 'type': 'RELEASE'}, {'date': '2022-10-12', 'type': 'RESET'}, {'date': '2023-02-22', 'type': 'RELEASE'}, {'date': '2023-12-04', 'type': 'RESET'}, {'date': '2023-12-10', 'type': 'RELEASE'}, {'date': '2024-05-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Georgetown University'}}}}