Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-02-26 @ 12:43 AM
Study NCT ID:
NCT02595203
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
2015-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mass Balance Recovery and Metabolic Profile of 14C Debio 1450 Following Single Oral and Intravenous Doses in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-14', 'studyFirstSubmitDate': '2015-11-02', 'studyFirstSubmitQcDate': '2015-11-02', 'lastUpdatePostDateStruct': {'date': '2016-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mass balance recovery after a single dose of radiolabelled Debio 1450 measured through total radioactivity excreted in expired air, urine and faeces', 'timeFrame': '168 hours after dosing (Day 8)'}, {'measure': 'Routes of metabolism and excretion after a single dose of radiolabelled Debio 1450 measured through total radioactivity concentrations in expired air, urine and fecaes', 'timeFrame': '168 hours after dosing (Day 8)'}, {'measure': 'Whole blood and plasma partitioning of total radioactivity after a single dose of radiolabelled Debio 1450 through measurement of total radioactivity levels in blood', 'timeFrame': '168 hours after dosing (Day 8)', 'description': 'Blood is collected within the 168 hours as follows:\n\n* IV infusion: Predose, 1, 1.85, 2.25, 2.5, 3, 4, 5, 8, 14, 18, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours after the infusion start time\n* Oral administration: Predose,15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours following the oral dose'}, {'measure': 'Percentage of participants with clinically significant change from baseline in vital signs, electrocardiogram, and/or laboratory parameters', 'timeFrame': '168 hours after dosing (Day 8)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioavailability'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are:\n\n* To determine the mass balance recovery (expired air, urine and faeces) and route and rate of elimination of 14C-Debio 1450.\n* To determine the metabolic profile of 14C-Debio 1450 in whole blood, plasma, urine and faeces.\n* To determine the pharmacokinetics of total radioactivity and of Debio 1450 (prodrug) and Debio 1452 (active moiety) in plasma and urine.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meets protocol-specified criteria for qualification and contraception\n* Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications\n* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures\n\nExclusion Criteria:\n\n* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters\n* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:\n\n 1. the safety or well-being of the participant or study staff\n 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)\n 3. the analysis of results"}, 'identificationModule': {'nctId': 'NCT02595203', 'briefTitle': 'Mass Balance Recovery and Metabolic Profile of 14C Debio 1450 Following Single Oral and Intravenous Doses in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Debiopharm International SA'}, 'officialTitle': 'A Phase I, Two-part, Open-label, Non-randomised Study to Investigate the Mass Balance Recovery and Metabolic Profile of 14C Debio 1450 Following Single Oral and Intravenous Doses in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'Debio 1450-105'}, 'secondaryIdInfos': [{'id': '2015-002604-87', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Cohort 1', 'description': 'Participants receive a single intravenous (IV) dose of 240 mg/3.7 megabecquerel (MBq) of \\[14C-pos 1\\]-Debio 1450 BES solution.', 'interventionNames': ['Drug: [14C-pos 1]-Debio 1450 BES Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Cohort 2', 'description': 'Participants receive a single oral dose of 240 mg/3.7 MBq of \\[14C-pos 1\\]-Debio 1450 BES solution.', 'interventionNames': ['Drug: [14C-pos 1]-Debio 1450 BES Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Cohort 3', 'description': 'Participants receive a single oral dose of 240 mg Debio 1450/37 kilobecquerel (kBq) of \\[14C-pos 25\\]-Debio 1450 BES solution.', 'interventionNames': ['Drug: [14C-pos 25]-Debio 1450 BES Solution']}], 'interventions': [{'name': '[14C-pos 1]-Debio 1450 BES Solution', 'type': 'DRUG', 'description': 'A solution containing Debio 1450 bis ethanolamine salt (BES) radiolabelled with carbon-14 (14C) at position 1', 'armGroupLabels': ['Part A: Cohort 1', 'Part A: Cohort 2']}, {'name': '[14C-pos 25]-Debio 1450 BES Solution', 'type': 'DRUG', 'description': 'A solution containing Debio 1450 BES radiolabelled with carbon-14 (14C) at position 25', 'armGroupLabels': ['Part B: Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 9LH', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Covance Clinical Research Unit (CRU) Ltd.', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Annick Ménétrey', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Debiopharm International, S.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Debiopharm International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}