Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-29 @ 8:16 AM
Study NCT ID:
NCT04634812
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2020-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mass Balance Study of KBP-5074 in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000716354', 'term': 'KBP-5074'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2020-11-12', 'studyFirstSubmitQcDate': '2020-11-12', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mass Balance of KBP-5074', 'timeFrame': 'up to 240 hours postdose', 'description': 'Percentage of total radioactivity recovered in urine and feces following a single dose \\[14C\\]-KBP-5074'}, {'measure': 'Pharmacokinetic Parameter: Area under the concentration-time curve from time 0 to infinity (AUC0-∞)', 'timeFrame': 'up to 216 hours postdose', 'description': 'Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma'}, {'measure': 'Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast)', 'timeFrame': 'up to 216 hours postdose', 'description': 'Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma'}, {'measure': 'Pharmacokinetic Parameter: Time of the maximum observed concentration (Cmax)', 'timeFrame': 'up to 216 hours postdose', 'description': 'Time of the maximum observed concentration (Cmax) - Plasma'}], 'secondaryOutcomes': [{'measure': 'Metabolite radioprofiling and identification in plasma, urine and feces', 'timeFrame': 'up to 240 hours postdose', 'description': 'Select plasma, urine, and fecal samples will be processed and subject to metabolite analysis by LC/MS \\& LC/MS/MS using high-resolution mass spectrometry.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Male Subjects', 'KBP-5074'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, open-label, nonrandomized, single-dose mass balance and metabolite identification study in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males, of any race, between 18 and 55 years of age, inclusive, at screening.\n2. Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening.\n3. In good health, determined by no clinically significant findings from medical history, physical examination (assessed only at check-in), 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \\[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\\] is not acceptable) at screening and check-in as assessed by the investigator (or designee).\n4. History of a minimum of 1 bowel movement per day.\n\nExclusion Criteria:\n\n1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, psychiatric, or other disorder, as determined by the investigator (or designee).\n2. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed; cholecystectomy will not be allowed).\n3. Positive urine drug screen, including cotinine, at screening; positive alcohol test result or positive urine drug screen, including cotinine, at check-in.\n4. Use of any drugs or substances known to be strong or moderate inhibitors or inducers of cytochrome P450 (CYP)3A4 or P-glycoprotein substrates within 30 days prior to study drug administration. Medications will be reviewed by the medical monitor to determine acceptability for the study."}, 'identificationModule': {'nctId': 'NCT04634812', 'briefTitle': 'Mass Balance Study of KBP-5074 in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Phase 1, Open-label, Study of the Absorption, Metabolism, and Excretion of [14C]-KBP-5074 Following a Single Oral Dose in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'KBP5074-1-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C]-KBP-5074', 'interventionNames': ['Drug: KBP-5074']}], 'interventions': [{'name': 'KBP-5074', 'type': 'DRUG', 'description': 'a single oral dose of \\[14C\\]-KBP-5074', 'armGroupLabels': ['[14C]-KBP-5074']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Covance Clinical Research Unit Inc.', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'James McCabe', 'role': 'STUDY_DIRECTOR', 'affiliation': 'KBP Biosciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KBP Biosciences', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Covance', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}