Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-02 @ 11:01 PM
Study NCT ID:
NCT04169893
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2019-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of TS-142 in Healthy Participants (Single Doses)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723815', 'term': 'TS-142'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2016-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2019-11-18', 'studyFirstSubmitQcDate': '2019-11-18', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)', 'timeFrame': 'Day 1 up to Day 8', 'description': 'Number of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) reported as mild, moderate, severe'}, {'measure': 'Area under the concentration-time curve AUC (tau)', 'timeFrame': '48 hours', 'description': 'Concentration of TS-142 and its metabolites in plasma'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'referencesModule': {'references': [{'pmid': '37563858', 'type': 'BACKGROUND', 'citation': 'Kambe D, Hasegawa S, Imadera Y, Mano Y, Matsushita I, Konno Y, Ogo H, Uchimura N, Uchiyama M. Pharmacokinetics, pharmacodynamics and safety profile of the dual orexin receptor antagonist vornorexant/TS-142 in healthy Japanese participants following single/multiple dosing: Randomized, double-blind, placebo-controlled phase-1 studies. Basic Clin Pharmacol Toxicol. 2023 Nov;133(5):576-591. doi: 10.1111/bcpt.13930. Epub 2023 Sep 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and pharmacokinetics of single dosing of TS-142 to healthy Japanese non-elderly participants in fasting and after meal condition.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) ≥18.5 and \\<25.0 kg/m\\^2 at screening inspection\n\nExclusion Criteria:\n\n* History of clinically relevant disease of some organ systems that may be considerd inappropriately for this study\n* History of drug and food allergy'}, 'identificationModule': {'nctId': 'NCT04169893', 'briefTitle': 'A Phase I Study of TS-142 in Healthy Participants (Single Doses)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taisho Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase I Study of TS-142 in Non-Elderly Healthy Participants (Single Doses) (A Single Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Non-Elderly Participants)', 'orgStudyIdInfo': {'id': 'TS142-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm Title: Placebo (fasting)', 'description': 'fasting', 'interventionNames': ['Drug: Placebo (fasting)', 'Drug: 1 mg of TS-142', 'Drug: 3 mg of TS-142', 'Drug: 10 mg of TS-142 (fasting)', 'Drug: 30 mg of TS-142']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (feeding)', 'description': 'after meal', 'interventionNames': ['Drug: Placebo (feeding)', 'Drug: 10 mg of TS-142 (feeding)']}, {'type': 'EXPERIMENTAL', 'label': 'TS-142, 1 mg', 'description': 'fasting', 'interventionNames': ['Drug: Placebo (fasting)', 'Drug: 3 mg of TS-142', 'Drug: 10 mg of TS-142 (fasting)', 'Drug: 30 mg of TS-142']}, {'type': 'EXPERIMENTAL', 'label': 'TS-142, 3 mg', 'description': 'fasting', 'interventionNames': ['Drug: 1 mg of TS-142', 'Drug: 3 mg of TS-142', 'Drug: 10 mg of TS-142 (fasting)', 'Drug: 30 mg of TS-142']}, {'type': 'EXPERIMENTAL', 'label': 'TS-142, 10 mg (fasting)', 'description': 'fasting', 'interventionNames': ['Drug: Placebo (fasting)', 'Drug: 1 mg of TS-142', 'Drug: 3 mg of TS-142', 'Drug: 10 mg of TS-142 (fasting)', 'Drug: 10 mg of TS-142 (feeding)', 'Drug: 30 mg of TS-142']}, {'type': 'EXPERIMENTAL', 'label': 'TS-142, 10 mg (feeding)', 'description': 'after meal', 'interventionNames': ['Drug: Placebo (feeding)', 'Drug: 10 mg of TS-142 (fasting)', 'Drug: 10 mg of TS-142 (feeding)']}, {'type': 'EXPERIMENTAL', 'label': 'TS-142, 30 mg', 'description': 'fasting', 'interventionNames': ['Drug: Placebo (fasting)', 'Drug: 1 mg of TS-142', 'Drug: 3 mg of TS-142', 'Drug: 10 mg of TS-142 (fasting)', 'Drug: 30 mg of TS-142']}], 'interventions': [{'name': 'Placebo (fasting)', 'type': 'DRUG', 'description': 'Participants will receive placebo once in fasting condition', 'armGroupLabels': ['Arm Title: Placebo (fasting)', 'TS-142, 1 mg', 'TS-142, 10 mg (fasting)', 'TS-142, 30 mg']}, {'name': 'Placebo (feeding)', 'type': 'DRUG', 'description': 'Participants will receive placebo once after meal condition', 'armGroupLabels': ['Placebo (feeding)', 'TS-142, 10 mg (feeding)']}, {'name': '1 mg of TS-142', 'type': 'DRUG', 'description': 'Participants will receive 1 mg of TS-142 once in fasting condition', 'armGroupLabels': ['Arm Title: Placebo (fasting)', 'TS-142, 10 mg (fasting)', 'TS-142, 3 mg', 'TS-142, 30 mg']}, {'name': '3 mg of TS-142', 'type': 'DRUG', 'description': 'Participants will receive 3 mg of TS-142 once in fasting condition', 'armGroupLabels': ['Arm Title: Placebo (fasting)', 'TS-142, 1 mg', 'TS-142, 10 mg (fasting)', 'TS-142, 3 mg', 'TS-142, 30 mg']}, {'name': '10 mg of TS-142 (fasting)', 'type': 'DRUG', 'description': 'Participants will receive 10 mg of TS-142 once in fasting condition', 'armGroupLabels': ['Arm Title: Placebo (fasting)', 'TS-142, 1 mg', 'TS-142, 10 mg (fasting)', 'TS-142, 10 mg (feeding)', 'TS-142, 3 mg', 'TS-142, 30 mg']}, {'name': '10 mg of TS-142 (feeding)', 'type': 'DRUG', 'description': 'Participants will receive 10 mg of TS-142 once after meal condition', 'armGroupLabels': ['Placebo (feeding)', 'TS-142, 10 mg (fasting)', 'TS-142, 10 mg (feeding)']}, {'name': '30 mg of TS-142', 'type': 'DRUG', 'description': 'Participants will receive 30 mg of TS-142 once in fasting condition', 'armGroupLabels': ['Arm Title: Placebo (fasting)', 'TS-142, 1 mg', 'TS-142, 10 mg (fasting)', 'TS-142, 3 mg', 'TS-142, 30 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fukuoka', 'country': 'Japan', 'facility': 'The medical facility selected by Taisho Pharmaceutical Co., Ltd', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}], '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'}}}}