Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-04 @ 5:18 PM
Study NCT ID:
NCT02434835
Status:
COMPLETED
Last Update Posted:
2016-04-18
First Post:
2015-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Absorption, Metabolism and Excretion Following a Single Oral Dose of [14C]KWA-0711 to Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'lastUpdateSubmitDate': '2016-04-15', 'studyFirstSubmitDate': '2015-04-21', 'studyFirstSubmitQcDate': '2015-05-04', 'lastUpdatePostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration-time curve (AUC) of total radioactivity, unchanged drug substance and its major metabolites', 'timeFrame': '240 hours'}, {'measure': 'Maximum observed plasma concentration (Cmax) of total radioactivity, unchanged drug substance and its major metabolites', 'timeFrame': '240 hours'}, {'measure': 'Cumulative radioactivity recovery in urine and feces', 'timeFrame': '240 hours'}, {'measure': 'Profiles of metabolites in plasma, urine and faeces', 'timeFrame': '240 hours'}], 'secondaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': '240 hours'}]}, 'conditionsModule': {'conditions': ['Healthy Male Subject']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the absorption, metabolism and excretion following a single oral dose of \\[14C\\]KWA-0711 to healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who are male, caucasian, and between 35 and 55 years of age, inclusive.\n* Subjects who have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive.\n* Subjects who have a body weight between 50 and 100 kg, inclusive.\n* Subjects must have regular bowel movements.\n\nExclusion Criteria:\n\n* Subjects who have an abnormality in heart rate, blood pressure , temperature or 12-lead ECG.\n* Subjects who are still participating in a clinical study or who have participated in a clinical study involving administration of an investigational drug in the 3 months prior to dose administration.\n* Subjects who have had a clinically significant illness within 4 weeks of dose administration as determined by the Investigator.\n* Subjects who have any clinically significant abnormal laboratory safety findings.\n* Subjects who have had an X ray or who have participated in any clinical trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.'}, 'identificationModule': {'nctId': 'NCT02434835', 'briefTitle': 'Study of Absorption, Metabolism and Excretion Following a Single Oral Dose of [14C]KWA-0711 to Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kissei Pharmaceutical Co., Ltd.'}, 'orgStudyIdInfo': {'id': 'KWA1101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C]KWA-0711', 'interventionNames': ['Drug: [14C]KWA-0711']}], 'interventions': [{'name': '[14C]KWA-0711', 'type': 'DRUG', 'armGroupLabels': ['[14C]KWA-0711']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leeds', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kissei Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}