Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 12:34 AM
Study NCT ID:
NCT04504760
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2020-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects
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': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2020-07-31', 'studyFirstSubmitQcDate': '2020-08-05', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events [Safety and Tolerability]', 'timeFrame': 'Up to 13 days', 'description': 'Number of participants with adverse events as assessed by CTCAE v5.0'}], 'secondaryOutcomes': [{'measure': 'Cmax [Pharmacokinetic]', 'timeFrame': 'Up to 10 days', 'description': 'Assessment of the Cmax of ONO-2910'}, {'measure': 'Tmax [Pharmacokinetic]', 'timeFrame': 'Up to 10 days', 'description': 'Assessment of the Tmax of ONO-2910'}, {'measure': 'AUC24h [Pharmacokinetic]', 'timeFrame': 'Up to 10 days', 'description': 'Assessment of the AUC24h of ONO-2910'}, {'measure': 'AUClast [Pharmacokinetic]', 'timeFrame': 'Up to 10 days', 'description': 'Assessment of the AUClast of ONO-2910'}, {'measure': 'AUCinf [Pharmacokinetic]', 'timeFrame': 'Up to 10 days', 'description': 'Assessment of the AUCinf of ONO-2910'}, {'measure': 'T1/2 [Pharmacokinetic]', 'timeFrame': 'Up to 10 days', 'description': 'Assessment of the T1/2 of ONO-2910'}, {'measure': 'CL/F [Pharmacokinetic]', 'timeFrame': 'Up to 10 days', 'description': 'Assessment of the CL/F of ONO-2910'}, {'measure': 'fe [Pharmacokinetic]', 'timeFrame': 'Up to 4 days', 'description': 'Assessment of the Vss of ONO-2910'}, {'measure': 'CLr [Pharmacokinetic]', 'timeFrame': 'Up to 4 days', 'description': 'Assessment of the CLr of ONO-2910'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'To investigate safety, tolerability and pharmacokinetics in Japanese and Caucasian subjects when ONO-2910 is administered as single and multiple doses orally.', 'detailedDescription': 'This study is the First in Human (FIH) study to investigate safety, tolerability and pharmacokinetics in healthy Japanese and Caucasian adult male subjects when ONO-2910 is administered as single and multiple doses orally. Also, the purpose of this study is to evaluate pharmacokinetics of oral single-dose of ONO-2910 in Japanese elderly male and female subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Japanese healthy adult male subjects (Part A and C)\n2. Japanese men or women after menopause aged ≥65 years and ≤74 years (Part B)\n3. Caucasian healthy adult male subjects (Part D)\n4. Age (at the time of informed consent): ≥20 years, ≤ 45 years (Part A, C and D)\n\nExclusion Criteria:\n\n1. Subjects currently with or with a history of disease\n2. Subjects with current or with a history of severe allergy to drugs or foods\n3. Subjects with current or with a history of drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT04504760', 'briefTitle': 'Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects', 'orgStudyIdInfo': {'id': 'ONO-2910-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ONO-2910 (Part A and B)', 'interventionNames': ['Drug: ONO-2910']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Part A)', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ONO-2910 (Part C and D)', 'interventionNames': ['Drug: ONO-2910']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Part C and D)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ONO-2910', 'type': 'DRUG', 'description': 'Single ascending dose of ONO-2910 will be administered orally.', 'armGroupLabels': ['ONO-2910 (Part A and B)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single dose of placebo will be administered orally.', 'armGroupLabels': ['Placebo (Part A)']}, {'name': 'ONO-2910', 'type': 'DRUG', 'description': 'Multiple ascending dose of ONO-2910 will be administered orally.', 'armGroupLabels': ['ONO-2910 (Part C and D)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Multiple dose of placebo will be administered orally.', 'armGroupLabels': ['Placebo (Part C and D)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Clinical Site 01', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Masaharu Komeno', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}