Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT05691660
Status:
COMPLETED
Last Update Posted:
2024-08-14
First Post:
2022-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of TAS3731 in Healthy Adults
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2022-11-24', 'studyFirstSubmitQcDate': '2023-01-18', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number and incidence rate of adverse events', 'timeFrame': 'Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16'}, {'measure': 'The number and incidence rate of adverse drug reactions', 'timeFrame': 'Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16'}, {'measure': 'Evaluation of Systolic and Diastolic blood pressure', 'timeFrame': 'Single dose cohort：Change from Baseline Systolic and Diastolic Blood Pressure at 7 days, Repeated dose cohort：Change from Baseline Systolic and Diastolic Blood Pressure at 16 days'}, {'measure': 'Evaluation of pulse rate', 'timeFrame': 'Single dose cohort：Change from Baseline pulse rate at 7 days, Repeated dose cohort：Change from Baseline pulse rate at 16 days'}, {'measure': 'Evaluation of body temperature', 'timeFrame': 'Single dose cohort：Change from Baseline body temperature at 7 days, Repeated dose cohort：Change from Baseline body temperature at 16 days'}, {'measure': 'Number of participants with abnormal laboratory values', 'timeFrame': 'Single dose cohort：Change in number of participants with abnormal laboratory values between baseline and 7 days, Repeated dose cohort：Change in number of participants with abnormal laboratory values between baseline and 16 days'}, {'measure': "Evaluation of QT interval corrected for heart rate using Fridericia's formula(QTcF) interval", 'timeFrame': 'Single dose cohort：Change from Baseline QTcF interval at 7 days, Repeated dose cohort：Change from Baseline QTcF interval at 16 days'}, {'measure': 'Evaluation of RR-interval', 'timeFrame': 'Single dose cohort：Change from Baseline Evaluation of RR-interval at 7 days, Repeated dose cohort：Change from Baseline Evaluation of RR-interval at 16 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adult Males']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety of single and repeated administration of TAS3731.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Healthy adult male subjects who provided written informed consent to participate in the study\n2. Aged 18 years or older and younger than 40 years at the time of informed consent\n3. Body weight of 50 kg or more at screening:\n4. Body mass index of 18.5 or more and less than 25.0 (Japanese) or less than 30.0 kg/m2 (Caucasian)\n5. Capable of oral intake.\n\nKey Exclusion Criteria\n\n1. Complications or history of diseases that may affect absorption, distribution, metabolism, or excretion of the investigational drug, such as hepatic/biliary tract disease, renal/urologic disease, or gastrointestinal disease. The stomach or small intestine has been resected.\n2. The 12-lead electrocardiogram at the time of the screening test was judged by the investigator to be inadequate for this study.\n3. Had any concurrent disease (including symptoms and signs; however, diseases that do not affect evaluations in the study such as asymptomatic pollinosis and wart are excluded)\n4. The patient has the following complications or a history of the following.\n\n 1. Had current or previous drug abuse (including use of illicit drugs) or alcoholism\n 2. Had current or previous hypersensitivity or allergy to drugs\n5. Suspected COVID-19 disease.'}, 'identificationModule': {'nctId': 'NCT05691660', 'briefTitle': 'A Study of TAS3731 in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiho Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Escalating Study of TAS3731 in Healthy Adults', 'orgStudyIdInfo': {'id': '10074010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single dose cohort', 'interventionNames': ['Drug: TAS3731 Dose1', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Repeated dose cohort Once daily (QD)', 'interventionNames': ['Drug: TAS3731 Dose2', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Repeated dose cohort Twice daily (BID)', 'interventionNames': ['Drug: TAS3731 Dose3', 'Drug: Placebo']}], 'interventions': [{'name': 'TAS3731 Dose1', 'type': 'DRUG', 'description': 'Oral administration,1 day,QD', 'armGroupLabels': ['Single dose cohort']}, {'name': 'TAS3731 Dose2', 'type': 'DRUG', 'description': 'Oral administration,7 days,QD', 'armGroupLabels': ['Repeated dose cohort Once daily (QD)']}, {'name': 'TAS3731 Dose3', 'type': 'DRUG', 'description': 'Oral administration,7 days,BID', 'armGroupLabels': ['Repeated dose cohort Twice daily (BID)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration, 1 day,QD', 'armGroupLabels': ['Single dose cohort']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration, 7 days,QD', 'armGroupLabels': ['Repeated dose cohort Once daily (QD)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration, 7 days,BID', 'armGroupLabels': ['Repeated dose cohort Twice daily (BID)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'A site selected by Taiho Pharmaceutical Co., Ltd.', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Taiho Pharmaceutical Co., Ltd.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taiho Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared according to the Sponsor policy on data sharing. Taiho policy on data sharing may be found at https://www.taiho.co.jp/en/science/policy/clinical\\_trial\\_information\\_disclosure\\_policy/index.html.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}