Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-03-09 @ 12:19 AM
Study NCT ID:
NCT02293967
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2014-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mass Balance Study of MT-1303
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624397', 'term': 'amiselimod'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-13', 'studyFirstSubmitDate': '2014-11-14', 'studyFirstSubmitQcDate': '2014-11-14', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total radioactivity in urine and faeces', 'timeFrame': 'up to 10 weeks'}], 'secondaryOutcomes': [{'measure': 'PK of total radioactivity in plasma', 'timeFrame': 'up to 10 weeks'}]}, 'conditionsModule': {'conditions': ['Relapsing-remitting Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '30231665', 'type': 'DERIVED', 'citation': 'Kifuji T, Inoue S, Furukawa M, Perez Madera B, Goto T, Kumagai H, Mair SJ, Kawaguchi A. Absorption, disposition and metabolic pathway of amiselimod (MT-1303) in healthy volunteers in a mass balance study. Xenobiotica. 2019 Sep;49(9):1033-1043. doi: 10.1080/00498254.2018.1525508. Epub 2018 Dec 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the absorption, metabolism and excretion of MT-1303 in healthy subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian male aged 30 to 65 at Screening.\n* Body weight of ≥60 kg, and a BMI ranging from 18.0 to 32.0 kg/m2 at Screening and Day -1.\n* Normal or not clinically significant ECG as defined by a HR between 50 and 100 bpm inclusive at Screening, Day -1 and pre-dose.\n* Vital signs within the following ranges at Screening and Day -1,Body temperature: 35.0 to 37.5 °C,SBP: 90 to 140 mmHg,DBP: 50 to 90 mmHg.\n* Regular daily bowel movements.\n\nExclusion Criteria:\n\n* 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 1999, shall participate in the study.\n* Previous medical history of tuberculosis, or in the opinion of the Investigator, a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections or fungal infections.\n* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardise the subject in case or participation in the study. The investigator should be guided by evidence of any of the following:\n\n * history of inflammatory bowel syndrome,gastritis, ulcers, gastrointestinal or rectal bleeding;\n * history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection'}, 'identificationModule': {'nctId': 'NCT02293967', 'briefTitle': 'Mass Balance Study of MT-1303', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C] MT-1303 After a Single Oral Dose to Healthy Male Subjects.', 'orgStudyIdInfo': {'id': 'MT-1303-E11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MT-1303', 'description': '\\[14C\\] MT-1303 after a single oral dose', 'interventionNames': ['Drug: MT-1303']}], 'interventions': [{'name': 'MT-1303', 'type': 'DRUG', 'armGroupLabels': ['MT-1303']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ruddington', 'state': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Investigational site', 'geoPoint': {'lat': 52.89254, 'lon': -1.14953}}], 'overallOfficials': [{'name': 'Pui Leung', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quotient Clinical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}