Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-27 @ 11:17 AM
Study NCT ID:
NCT04223232
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2019-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'frederic.sedel@medday-pharma.com', 'phone': '+33 1 80 40 14 40', 'title': 'Dr Frédéric SEDEL, Chief Scientific Officer and Co-founder', 'organization': 'MedDay Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From Day -28 to Day 8', 'eventGroups': [{'id': 'EG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA; v 22.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA; v 22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mass Balance Recovery of Total Radioactivity: CumAe (Urine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'categories': [{'measurements': [{'value': '70.9', 'spread': '16.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 312 hours post-dose', 'description': 'Cumulative amount of total radioactivity excreted in urine Measured at 0/12/24/48/72/96/120/144/168/192/216/240/264/288/312 hours', 'unitOfMeasure': 'mg equiv', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mass Balance Recovery of Total Radioactivity: Cum%Ae (Urine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'categories': [{'measurements': [{'value': '70.786', 'spread': '16.874', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 312 hours post dose', 'description': 'Cumulative amount of total radioactivity excreted in urine expressed as a percentage of the radioactive dose administered Measured at 0/0.5/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168/192/216/240/264/288/312 hours.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mass Balance Recovery of Total Radioactivity: CumAe (Faeces)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'spread': '8.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 312 hours post-dose', 'description': 'Cumulative amount of total radioactivity excreted in faeces Measured at 0/0.5/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168/192/216/240/264/288/312 hours.', 'unitOfMeasure': 'mg equiv', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mass Balance Recovery of Total Radioactivity: Cum%Ae (Faeces)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'categories': [{'measurements': [{'value': '16.009', 'spread': '8.617', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 312 hours post dose', 'description': 'Cumulative amount of total radioactivity excreted in faeces expressed as a percentage of the radioactive dose administered Measured at 0/0.5/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168/192/216/240/264/288/312 hours.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mass Balance Recovery of Total Radioactivity: CumAe(Total)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'categories': [{'measurements': [{'value': '86.9', 'spread': '9.25', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 312 hours post dose', 'description': 'Cumulative amount of total radioactivity excreted in urine and faeces combined Measured at 0/0.5/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168/192/216/240/264/288/312 hours.', 'unitOfMeasure': 'mg equiv', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mass Balance Recovery of Total Radioactivity: Cum%Ae (Total)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'categories': [{'measurements': [{'value': '86.795', 'spread': '9.235', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 312 hours post dose', 'description': 'Cumulative amount of total radioactivity excreted in urine and faeces combined expressed as a percentage of the radioactive dose administered Measured at 0/0.5/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168/192/216/240/264/288/312 hours.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Prior to the First Measurable Concentration (Tlag) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'title': 'MD1003', 'categories': [{'measurements': [{'value': '0.083', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.50'}]}]}, {'title': 'Bisnorbiotin', 'categories': [{'measurements': [{'value': '0.753', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '1.50'}]}]}, {'title': 'Biotin Sulfoxide', 'categories': [{'measurements': [{'value': '0.753', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '1.50'}]}]}, {'title': 'Total radioactivity', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Plasma Concentration (Tmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'title': 'MD1003', 'categories': [{'measurements': [{'value': '2.086', 'groupId': 'OG000', 'lowerLimit': '1.52', 'upperLimit': '3.00'}]}]}, {'title': 'Bisnorbiotin', 'categories': [{'measurements': [{'value': '4.011', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '6.00'}]}]}, {'title': 'Biotin Sulfoxide', 'categories': [{'measurements': [{'value': '2.667', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '4.00'}]}]}, {'title': 'Total radioactivity', 'categories': [{'measurements': [{'value': '2.667', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'title': 'MD1003', 'categories': [{'measurements': [{'value': '387', 'groupId': 'OG000', 'lowerLimit': '325', 'upperLimit': '416'}]}]}, {'title': 'Bisnorbiotin', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '59.0'}]}]}, {'title': 'Biotin Sulfoxide', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '9.70', 'upperLimit': '18.9'}]}]}, {'title': 'Total radioactivity', 'categories': [{'measurements': [{'value': '501', 'groupId': 'OG000', 'lowerLimit': '469', 'upperLimit': '543'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-last)) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'title': 'MD1003', 'categories': [{'measurements': [{'value': '3350', 'groupId': 'OG000', 'lowerLimit': '2750', 'upperLimit': '4480'}]}]}, {'title': 'Bisnorbiotin', 'categories': [{'measurements': [{'value': '514', 'groupId': 'OG000', 'lowerLimit': '246', 'upperLimit': '890'}]}]}, {'title': 'Biotin Sulfoxide', 'categories': [{'measurements': [{'value': '74.3', 'groupId': 'OG000', 'lowerLimit': '47.4', 'upperLimit': '123'}]}]}, {'title': 'Total radioactivity', 'categories': [{'measurements': [{'value': '2690', 'groupId': 'OG000', 'lowerLimit': '2490', 'upperLimit': '3310'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.', 'unitOfMeasure': 'ng.h/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under Plasma Concentration Curve From 0 Time Extrapolated to Infinity (AUC(0-inf)) for MD1003 and Total Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'title': 'MD1003', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3650', 'groupId': 'OG000', 'lowerLimit': '3010', 'upperLimit': '4750'}]}]}, {'title': 'Total radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2850', 'groupId': 'OG000', 'lowerLimit': '2670', 'upperLimit': '3060'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.', 'unitOfMeasure': 'ng.h/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For total radioactivity: for 3 patients, extrapolated portion of AUC(0-inf) \\>20%.'}, {'type': 'SECONDARY', 'title': 'Percentage of AUC(0-extrap) Extrapolated Beyond the Last Measurable Concentration for MD1003 and Total Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'title': 'MD1003', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.405', 'groupId': 'OG000', 'lowerLimit': '5.76', 'upperLimit': '11.33'}]}]}, {'title': 'Total radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.171', 'groupId': 'OG000', 'lowerLimit': '10.15', 'upperLimit': '18.82'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.', 'unitOfMeasure': 'percentage of AUC(0-extrap)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For total radioactivity: for 3 patients, extrapolated portion of AUC(0-inf) \\>20%.'}, {'type': 'SECONDARY', 'title': 'Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-12)) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'title': 'MD1003', 'categories': [{'measurements': [{'value': '1760', 'spread': '16.50', 'groupId': 'OG000'}]}]}, {'title': 'Bisnorbiotin', 'categories': [{'measurements': [{'value': '279', 'spread': '26.4', 'groupId': 'OG000'}]}]}, {'title': 'Biotin Sulfoxide', 'categories': [{'measurements': [{'value': '90.1', 'spread': '23.7', 'groupId': 'OG000'}]}]}, {'title': 'Total radioactivity', 'categories': [{'measurements': [{'value': '2680', 'spread': '10.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.', 'unitOfMeasure': 'ng.h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lambda-z for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'title': 'MD1003', 'categories': [{'measurements': [{'value': '0.02302', 'groupId': 'OG000', 'lowerLimit': '0.0180', 'upperLimit': '0.0269'}]}]}, {'title': 'Bisnorbiotin', 'categories': [{'measurements': [{'value': '0.02251', 'groupId': 'OG000', 'lowerLimit': '0.0165', 'upperLimit': '0.0285'}]}]}, {'title': 'Biotin Sulfoxide', 'categories': [{'measurements': [{'value': '0.11829', 'groupId': 'OG000', 'lowerLimit': '0.0324', 'upperLimit': '0.1683'}]}]}, {'title': 'Total radioactivity', 'categories': [{'measurements': [{'value': '0.20071', 'groupId': 'OG000', 'lowerLimit': '0.0756', 'upperLimit': '0.3762'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.', 'unitOfMeasure': '1/Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Clearance (CL/F) for MD1003', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'categories': [{'measurements': [{'value': '465', 'groupId': 'OG000', 'lowerLimit': '351', 'upperLimit': '554'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Clearance (Vz/F) for MD1003', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'categories': [{'measurements': [{'value': '1230', 'groupId': 'OG000', 'lowerLimit': '816', 'upperLimit': '1560'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.', 'unitOfMeasure': 'L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Elimination Half Life (t1/2) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'title': 'MD1003', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.625', 'groupId': 'OG000', 'lowerLimit': '25.74', 'upperLimit': '38.51'}]}]}, {'title': 'Bisnorbiotin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.176', 'groupId': 'OG000', 'lowerLimit': '24.29', 'upperLimit': '42.065'}]}]}, {'title': 'Biotin Sulfoxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.010', 'groupId': 'OG000', 'lowerLimit': '4.12', 'upperLimit': '21.42'}]}]}, {'title': 'Total radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.502', 'groupId': 'OG000', 'lowerLimit': '1.84', 'upperLimit': '9.17'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0//1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For Bisnorbiotin: terminal slopes could not be reliably determined for all, due to an unacceptable coefficient of determination (ie, R2 \\< 0.9).\n\nFor Biotin sulfoxide: terminal slopes could not be reliably determined all, due to an unacceptable coefficient of determination (ie, R2 \\< 0.9) or insufficient data points after Cmax.'}, {'type': 'SECONDARY', 'title': 'MPR Cmax for Bisnorbiotin and Biotin Sulfoxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'title': 'Bisnorbiotin', 'categories': [{'measurements': [{'value': '0.1327', 'groupId': 'OG000', 'lowerLimit': '0.074', 'upperLimit': '0.174'}]}]}, {'title': 'Biotin Sulfoxide', 'categories': [{'measurements': [{'value': '0.0349', 'groupId': 'OG000', 'lowerLimit': '0.028', 'upperLimit': '0.044'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'MPR = metabolite to parent ratio Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.', 'unitOfMeasure': 'none (ratio)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MPR AUC(0-inf) for Bisnorbiotin and Biotin Sulfoxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'title': 'Bisnorbiotin', 'categories': [{'measurements': [{'value': '0.1731', 'groupId': 'OG000', 'lowerLimit': '0.082', 'upperLimit': '0.267'}]}]}, {'title': 'Biotin sulfoxide', 'categories': [{'measurements': [{'value': '0.0204', 'groupId': 'OG000', 'lowerLimit': '0.014', 'upperLimit': '0.026'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'MPR = metabolite to parent ratio Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.', 'unitOfMeasure': 'none (ratio)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Whole Blood: Plasma Concentration Ratios of Total Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'title': '1 H', 'categories': [{'measurements': [{'value': '1.298', 'spread': '5.0', 'groupId': 'OG000'}]}]}, {'title': '4 H', 'categories': [{'measurements': [{'value': '0.931', 'spread': '14.6', 'groupId': 'OG000'}]}]}, {'title': '8 H', 'categories': [{'measurements': [{'value': '1.365', 'spread': '7.0', 'groupId': 'OG000'}]}]}, {'title': '12 H', 'categories': [{'measurements': [{'value': '1.708', 'spread': '9.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose to 168 hours post-dose', 'description': 'Total radioactivity in whole blood versus total radioactivity in plasma concentration ratios at time intervals following a single oral administration of 100mg \\[14C\\]-MD1003 Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.', 'unitOfMeasure': '% radioactivity whole blood/plasma', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Overall period', 'description': '2 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Adverse Drug Reactions as Assessed by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Overall period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure in mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'title': '1H', 'categories': [{'measurements': [{'value': '0.7', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': '4H', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '8.0', 'groupId': 'OG000'}]}]}, {'title': '24H', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '10.3', 'groupId': 'OG000'}]}]}, {'title': '72H', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '11.4', 'groupId': 'OG000'}]}]}, {'title': 'Discharge', 'categories': [{'measurements': [{'value': '0.5', 'spread': '6.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to Day 10', 'description': 'Change from baseline measure (defined as Day 1, pre-dose). Measured at screening/Pre-dose/1/4/24/72/168 hours.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diastolic Blood Pressure in mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'title': '1H', 'categories': [{'measurements': [{'value': '3.2', 'spread': '5.9', 'groupId': 'OG000'}]}]}, {'title': '4H', 'categories': [{'measurements': [{'value': '2.5', 'spread': '6.1', 'groupId': 'OG000'}]}]}, {'title': '24H', 'categories': [{'measurements': [{'value': '2.0', 'spread': '6.6', 'groupId': 'OG000'}]}]}, {'title': '72H', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '5.8', 'groupId': 'OG000'}]}]}, {'title': 'Discharge', 'categories': [{'measurements': [{'value': '4.7', 'spread': '6.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to Day 10', 'description': 'Change from baseline measure (defined as Day 1, pre-dose). Measured at screening/Pre-dose/1/4/24/72/168 hours.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Heart Rate in Beats Per Minute', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'title': '1H', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '3.0', 'groupId': 'OG000'}]}]}, {'title': '4H', 'categories': [{'measurements': [{'value': '-4.0', 'spread': '4.8', 'groupId': 'OG000'}]}]}, {'title': '24H', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '5.5', 'groupId': 'OG000'}]}]}, {'title': '72H', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '6.0', 'groupId': 'OG000'}]}]}, {'title': 'Discharge', 'categories': [{'measurements': [{'value': '3.3', 'spread': '9.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to Day 10', 'description': 'Change from baseline measure (defined as Day 1, pre-dose). Measured at screening/Pre-dose/1/4/24/72/168 hours.', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ECG (Electrocardiogram) QTcF Interval in Milliseconds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'classes': [{'title': '1H', 'categories': [{'measurements': [{'value': '2.2', 'spread': '6.9', 'groupId': 'OG000'}]}]}, {'title': '4H', 'categories': [{'measurements': [{'value': '2.7', 'spread': '3.9', 'groupId': 'OG000'}]}]}, {'title': '24H', 'categories': [{'measurements': [{'value': '1.0', 'spread': '4.6', 'groupId': 'OG000'}]}]}, {'title': 'Discharge', 'categories': [{'measurements': [{'value': '1.0', 'spread': '11.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to Day 10', 'description': 'Change from baseline measure (defined as Day 1, pre-dose). Measured at screening/Pre-dose/1/4/24/72/168 hours.', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg\n\n\\[14C\\]-MD1003: single oral dose of 100mg \\[14C\\]-MD1003'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'spread': '12.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-12', 'size': 909871, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-28T11:54', 'hasProtocol': True}, {'date': '2019-12-02', 'size': 1556125, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-28T11:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-29', 'studyFirstSubmitDate': '2019-12-13', 'resultsFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2020-01-07', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-29', 'studyFirstPostDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mass Balance Recovery of Total Radioactivity: CumAe (Urine)', 'timeFrame': 'Pre-dose to 312 hours post-dose', 'description': 'Cumulative amount of total radioactivity excreted in urine Measured at 0/12/24/48/72/96/120/144/168/192/216/240/264/288/312 hours'}, {'measure': 'Mass Balance Recovery of Total Radioactivity: Cum%Ae (Urine)', 'timeFrame': 'Pre-dose to 312 hours post dose', 'description': 'Cumulative amount of total radioactivity excreted in urine expressed as a percentage of the radioactive dose administered Measured at 0/0.5/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168/192/216/240/264/288/312 hours.'}, {'measure': 'Mass Balance Recovery of Total Radioactivity: CumAe (Faeces)', 'timeFrame': 'Pre-dose to 312 hours post-dose', 'description': 'Cumulative amount of total radioactivity excreted in faeces Measured at 0/0.5/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168/192/216/240/264/288/312 hours.'}, {'measure': 'Mass Balance Recovery of Total Radioactivity: Cum%Ae (Faeces)', 'timeFrame': 'Pre-dose to 312 hours post dose', 'description': 'Cumulative amount of total radioactivity excreted in faeces expressed as a percentage of the radioactive dose administered Measured at 0/0.5/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168/192/216/240/264/288/312 hours.'}, {'measure': 'Mass Balance Recovery of Total Radioactivity: CumAe(Total)', 'timeFrame': 'Pre-dose to 312 hours post dose', 'description': 'Cumulative amount of total radioactivity excreted in urine and faeces combined Measured at 0/0.5/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168/192/216/240/264/288/312 hours.'}, {'measure': 'Mass Balance Recovery of Total Radioactivity: Cum%Ae (Total)', 'timeFrame': 'Pre-dose to 312 hours post dose', 'description': 'Cumulative amount of total radioactivity excreted in urine and faeces combined expressed as a percentage of the radioactive dose administered Measured at 0/0.5/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168/192/216/240/264/288/312 hours.'}], 'secondaryOutcomes': [{'measure': 'Time Prior to the First Measurable Concentration (Tlag) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.'}, {'measure': 'Time of Maximum Plasma Concentration (Tmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.'}, {'measure': 'Maximum Plasma Concentration (Cmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.'}, {'measure': 'Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-last)) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.'}, {'measure': 'Area Under Plasma Concentration Curve From 0 Time Extrapolated to Infinity (AUC(0-inf)) for MD1003 and Total Radioactivity', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.'}, {'measure': 'Percentage of AUC(0-extrap) Extrapolated Beyond the Last Measurable Concentration for MD1003 and Total Radioactivity', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.'}, {'measure': 'Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-12)) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.'}, {'measure': 'Lambda-z for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.'}, {'measure': 'Plasma Clearance (CL/F) for MD1003', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.'}, {'measure': 'Plasma Clearance (Vz/F) for MD1003', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.'}, {'measure': 'Elimination Half Life (t1/2) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'Measured at 0//1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.'}, {'measure': 'MPR Cmax for Bisnorbiotin and Biotin Sulfoxide', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'MPR = metabolite to parent ratio Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.'}, {'measure': 'MPR AUC(0-inf) for Bisnorbiotin and Biotin Sulfoxide', 'timeFrame': 'Pre-dose to 168 hours', 'description': 'MPR = metabolite to parent ratio Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.'}, {'measure': 'Whole Blood: Plasma Concentration Ratios of Total Radioactivity', 'timeFrame': 'Pre-dose to 168 hours post-dose', 'description': 'Total radioactivity in whole blood versus total radioactivity in plasma concentration ratios at time intervals following a single oral administration of 100mg \\[14C\\]-MD1003 Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.'}, {'measure': 'Number of Subjects With Adverse Events (AEs)', 'timeFrame': 'Overall period', 'description': '2 months'}, {'measure': 'Number of Subjects With Adverse Drug Reactions as Assessed by Investigator', 'timeFrame': 'Overall period'}, {'measure': 'Change From Baseline in Systolic Blood Pressure in mmHg', 'timeFrame': 'Pre-dose to Day 10', 'description': 'Change from baseline measure (defined as Day 1, pre-dose). Measured at screening/Pre-dose/1/4/24/72/168 hours.'}, {'measure': 'Change From Baseline in Diastolic Blood Pressure in mmHg', 'timeFrame': 'Pre-dose to Day 10', 'description': 'Change from baseline measure (defined as Day 1, pre-dose). Measured at screening/Pre-dose/1/4/24/72/168 hours.'}, {'measure': 'Change From Baseline in Heart Rate in Beats Per Minute', 'timeFrame': 'Pre-dose to Day 10', 'description': 'Change from baseline measure (defined as Day 1, pre-dose). Measured at screening/Pre-dose/1/4/24/72/168 hours.'}, {'measure': 'Change From Baseline in ECG (Electrocardiogram) QTcF Interval in Milliseconds', 'timeFrame': 'Pre-dose to Day 10', 'description': 'Change from baseline measure (defined as Day 1, pre-dose). Measured at screening/Pre-dose/1/4/24/72/168 hours.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This single-center, open-label, non randomized Phase I study is being conducted to investigate the pharmacokinetics, mass balance and metabolite profiling and identification after a single oral dose of 100mg of \\[14C\\]-MD1003 in 6 healthy males subjects. The radioactivity will be followed in the blood, urine and faeces to study MD1003 metabolism.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy males\n2. Age 30 to 65 years of age at the time of signing informed consent\n3. Body mass index (BMI) of 18.0 to 30.0 kg/m2 as measured at screening\n4. Must be willing and able to communicate and participate in the whole study\n5. Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)\n6. Must provide written informed consent\n7. Must agree to adhere to the contraception requirements of the protocol\n\nExclusion Criteria:\n\n1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1\n2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee\n3. Subjects who have previously been enrolled in this study\n4. History of any drug or alcohol abuse in the past 2 years\n5. Regular alcohol consumption in males \\>21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)\n6. A confirmed positive alcohol breath test at screening or admission\n7. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission\n8. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months\n9. Subjects with pregnant or lactating partners\n10. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study\n11. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening\n12. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are allowed\n13. Confirmed positive drugs of abuse test result (drugs of abuse tests are listed in the protocol)\n14. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results\n15. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of \\<80 mL/min using the Cockcroft-Gault equation\n16. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator\n17. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients\n18. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active\n19. Donation or loss of greater than 400 mL of blood within the previous 3 months\n20. Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g of paracetamol per day), herbal remedies, vitamin B5 or dietary supplements containing lipoic acid in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the PI\n21. Subjects who have had any intake of biotin (including as a nutritional supplement) in the 14 days before IMP administration\n22. Failure to satisfy the investigator of fitness to participate for any other reason"}, 'identificationModule': {'nctId': 'NCT04223232', 'briefTitle': 'Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedDay Pharmaceuticals SA'}, 'officialTitle': 'An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'MD1003CT2019-03MB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MD1003', 'description': 'radiolabeled 14C MD1003 (High Dose Biotin) 100mg', 'interventionNames': ['Drug: [14C]-MD1003']}], 'interventions': [{'name': '[14C]-MD1003', 'type': 'DRUG', 'description': 'single oral dose of 100mg \\[14C\\]-MD1003', 'armGroupLabels': ['MD1003']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Sciences', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Somasekhara Menakuru, MS, MRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quotient Sciences Nottingham, UK, NG116JS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedDay Pharmaceuticals SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quotient Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}