Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-20 @ 1:46 PM
Study NCT ID:
NCT02900235
Status:
COMPLETED
Last Update Posted:
2017-01-31
First Post:
2016-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mass Balance Study of MT-3995
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719999', 'term': 'apararenone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-29', 'studyFirstSubmitDate': '2016-08-17', 'studyFirstSubmitQcDate': '2016-09-08', 'lastUpdatePostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total radioactivity in urine and faeces', 'timeFrame': 'up to 99 days'}, {'measure': 'Maximum observed plasma concentration [Cmax]', 'timeFrame': 'up to 99 days'}, {'measure': 'Time at which Cmax occurs [tmax]', 'timeFrame': 'up to 99 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to the last measurable concentration [AUC0-t]', 'timeFrame': 'up to 99 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to infinity [AUC0-∞]', 'timeFrame': 'up to 99 days'}, {'measure': 'Apparent terminal elimination half-life [t1/2]', 'timeFrame': 'up to 99 days'}, {'measure': 'Terminal elimination rate constant [Kel]', 'timeFrame': 'up to 99 days'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability as measured by adverse events (AEs)', 'timeFrame': 'up to 99 days'}, {'measure': 'Safety and tolerability as measured by vital signs', 'timeFrame': 'up to 99 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the absorption, metabolism and excretion of MT-3995 in healthy subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide written informed consent to participate in the study\n* Caucasian male aged at least 35 years at Screening\n* Healthy and free from clinically significant illness or disease at Screening and Day-1\n* A body weight of 60 to 110 kg at Screening and Day-1\n* Vital signs within the following ranges at Screening, Day-1 and Pre-dose:\n\n * Body temperature : 35.0°C to 37.5°C\n * Systolic blood pressure: 90 to 140 mmHg\n * Diastolic blood pressure: 50 to 90 mmHg\n* Regular daily bowel movements\n\nExclusion Criteria:\n\n* Presence or history of severe adverse reaction or allergy to any medicinal product\n* Participation in more than three clinical studies of an Investigational Medicinal Product (IMP) in the previous year or participated in a clinical study of any IMP within 12 weeks or five half-lives\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 of 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 considered clinically significant by the Investigator\n * History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bowel resection\n * History or clinical evidence of pancreatic injury or pancreatitis'}, 'identificationModule': {'nctId': 'NCT02900235', 'briefTitle': 'Mass Balance Study of MT-3995', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-MT-3995 After a Single Oral Dose to Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'MT-3995-E11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MT-3995', 'description': '\\[14C\\]-MT-3995 after a single oral dose', 'interventionNames': ['Drug: MT-3995']}], 'interventions': [{'name': 'MT-3995', 'type': 'DRUG', 'armGroupLabels': ['MT-3995']}]}, 'contactsLocationsModule': {'locations': [{'city': 'City Name', 'country': 'United Kingdom', 'facility': 'Investigational center'}], 'overallOfficials': [{'name': 'General Manager', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanabe Pharma Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}