Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:45 AM
Study NCT ID:
NCT03595202
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2018-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of TS-143 in Healthy Adult Male Subjects (Multiple-Dose Administration)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2018-04-18', 'studyFirstSubmitQcDate': '2018-07-20', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of subjects with adverse events', 'timeFrame': '18 days', 'description': 'To evaluate the safety of TS-143 given single administration in healthy volunteers by incidence of subjects with adverse events which include abnormal electrocardiograms, vital signs, and clinical laboratory parameters.'}, {'measure': 'Plasma concentrations of unchanged form (ng/mL)', 'timeFrame': '13 days'}, {'measure': 'Urinary excretions of unchanged form (ng/mL)', 'timeFrame': '12 days'}, {'measure': 'Serum EPO concentration', 'timeFrame': '13 days'}, {'measure': 'Reticulocyte count', 'timeFrame': '13 days'}, {'measure': 'Plasma vascular endothelial growth factor (VEGF) concentration', 'timeFrame': '13 days'}, {'measure': 'Serum iron (μg／dL)', 'timeFrame': '13 days'}, {'measure': 'Total iron binding capacity（μg／dL）', 'timeFrame': '13 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'To investigate the safety, pharmacokinetics and pharmacodynamics of TS-143 when administered 3 times a day for 10 days to healthy Japanese adult males using placebo-controlled, double-blind, dose escalation study design.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with a BMI of 18.5 to less than 25.0 at the time of the screening tests\n* Subjects judged by the principal investigator or a subinvestigator to be appropriate for participation in the study based on the results of the screening tests and the tests conducted before the investigational drug treatment on Day 1\n* Subjects capable of receiving an explanation of this study before participation, understanding the details, and providing written informed consent themselves\n\nExclusion Criteria:\n\n1. Subjects meeting any of the following criteria in the results of screening tests, tests conducted on the day before the first investigational treatment (Day -1), and tests conducted before the investigational drug treatment on the morning of Day 1:\n\n * Red blood cell count: ≥535 × 10\\^4 /μL\n * Hemoglobin: ≥16.2 g/dL\n * Hematocrit: ≥47.5%\n * Reticulocyte rate: Outside of the reference value range\n2. Subjects meeting any of the following criteria in the screening tests:\n\n * Serum EPO concentration: Outside of the reference value range\n * Ferritin: ≤30 ng/mL or \\>upper limit of the reference value\n3. Subjects meeting any of the following criteria in the vital signs in the screening tests and the tests conducted before the investigational drug treatment on the morning of Day 1:\n\n * Blood pressure: Systolic blood pressure ≥140 mmHg, or diastolic blood pressure ≥90 mmHg\n * Pulse rate: \\<40 bpm, or ≥100 bpm\n * Body temperature: ≥37.5°C'}, 'identificationModule': {'nctId': 'NCT03595202', 'briefTitle': 'Clinical Study of TS-143 in Healthy Adult Male Subjects (Multiple-Dose Administration)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taisho Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Phase I Clinical Study of TS-143 in Healthy Adult Male Subjects (Multiple-Dose Administration)', 'orgStudyIdInfo': {'id': 'TS143-01-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Step1:4㎎ TID', 'description': 'TS-143 12mg total dose/day or Placebo', 'interventionNames': ['Drug: TS-143', 'Drug: Placebo']}, {'type': 'OTHER', 'label': 'Step2:11㎎ TID', 'description': 'TS-143 33mg total dose/day or Placebo', 'interventionNames': ['Drug: TS-143', 'Drug: Placebo']}], 'interventions': [{'name': 'TS-143', 'type': 'DRUG', 'description': 'Subjects should take 4 capsules once and 3 times per day in step 1. Subjects should take 2 capsules once and 3 times per day in step 2.', 'armGroupLabels': ['Step1:4㎎ TID', 'Step2:11㎎ TID']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects should take 4 capsules once and 3 times per day in step 1. Subjects should take 2 capsules once and 3 times per day in step 2.', 'armGroupLabels': ['Step1:4㎎ TID', 'Step2:11㎎ TID']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Taisho Pharmaceutical Co., Ltd selected site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Shigeru Okuyama', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taisho Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taisho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}