Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT03444818
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2018-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Determine the Absorption, Metabolism, and Excretion of [14C]-E6007 After a Single Oral Administration in Healthy Male Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2018-02-19', 'studyFirstSubmitQcDate': '2018-02-19', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum concentration (Cmax) of E6007 derived from whole blood', 'timeFrame': 'Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose'}, {'measure': 'Area under the concentration-time curve (AUC) from time zero to infinity (AUC[0-∞]) postdose of E6007', 'timeFrame': 'Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose'}, {'measure': 'Total radioactivity derived from whole blood', 'timeFrame': 'Up to 11 days'}, {'measure': 'Total radioactivity in urine', 'timeFrame': 'Up to 11 days'}, {'measure': 'Total radioactivity in feces', 'timeFrame': 'Up to 11 days'}], 'secondaryOutcomes': [{'measure': 'Number of participants with any serious adverse event', 'timeFrame': 'Up to 11 days'}, {'measure': 'Number of participants with any non-serious adverse event', 'timeFrame': 'Up to 11 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['E6007', 'Pharmacokinetics', 'Radioactivity'], 'conditions': ['Healthy Male Participants']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to evaluate the absorption, metabolism, and excretion of a single oral dose of \\[14C\\]-E6007 in healthy male participants.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 30 to 55 years of age\n* Body mass index between 18.5 and 30.0 kilograms per meters squared (kg/m\\^2), and a total body weight between 50 and 100 kilograms (kg)\n* In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead electrocardiogram, vital sign measurements, and clinical laboratory evaluations\n* Males will agree to use contraception\n* Able to comprehend and willing to sign an informed consent form and to abide by the study restrictions\n\nExclusion Criteria:\n\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder\n* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance\n* 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)\n* Significant history or clinical manifestation of hemorrhoids\n* History of alcoholism or drug/chemical abuse within 2 years prior to Check-in\n* Positive hepatitis panel and/or positive human immunodeficiency virus test\n* Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to Check-in\n* Use or intend to use any prescription medications/products within 14 days prior to Check-in\n* Participants in receipt of a live vaccine within 30 days prior to the first dose administration or who plan to receive a live vaccine during the study and for 14 days after the dose of study drug\n* Use of tobacco or nicotine containing products within 3 months prior to Check-in\n* Receipt of blood products within 2 months prior to Check-in\n* Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening\n* Participants with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in\n* Participants who have participated in any clinical trial involving a radiolabelled investigational product within 12 months prior to Check-in'}, 'identificationModule': {'nctId': 'NCT03444818', 'briefTitle': 'A Study to Determine the Absorption, Metabolism, and Excretion of [14C]-E6007 After a Single Oral Administration in Healthy Male Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Phase I, Open-label, Study to Determine the Absorption, Metabolism, and Excretion of [14C]-E6007 After a Single Oral Administration in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'E6007-CP3'}, 'secondaryIdInfos': [{'id': '2017-004119-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C]-E6007', 'description': 'Participants will receive a single oral dose of 60 milligrams (mg) of \\[14C\\]-E6007.', 'interventionNames': ['Drug: [14C]-E6007']}], 'interventions': [{'name': '[14C]-E6007', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['[14C]-E6007']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'Covance Clinical Research Unit (CRU) Ltd.', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EA Pharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}