Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-01-16 @ 12:44 PM
Study NCT ID:
NCT01613703
Status:
COMPLETED
Last Update Posted:
2013-06-03
First Post:
2012-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ONO-2952 Single-dose PET Study in Healthy Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607300', 'term': 'ONO-2952'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'lastUpdateSubmitDate': '2013-05-31', 'studyFirstSubmitDate': '2012-06-05', 'studyFirstSubmitQcDate': '2012-06-06', 'lastUpdatePostDateStruct': {'date': '2013-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the brain TSPO occupancy of ONO-2952 in healthy adult subjects after a single dose using [11C]PBR28 as a specific PET ligand for TSPO', 'timeFrame': '2 days'}], 'secondaryOutcomes': [{'measure': 'To evaluate the relationship between TSPO occupancy and the plasma concentration of ONO-2952', 'timeFrame': '2 days'}, {'measure': 'To investigate the safety and tolerability of ONO-2952 in healthy adult subjects', 'timeFrame': '14 days'}]}, 'conditionsModule': {'keywords': ['ONO-2952', 'Healthy adult subjects', 'single doe', 'PET study', 'Safety', 'Tolerability'], 'conditions': ['Healthy Adult Subjects']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the brain TSPO occupancy of ONO-2952 in healthy adult subjects after a single dose using \\[11C\\]PBR28 as a specific PET ligand for TSPO. The secondary objective is to evaluate the relationship between TSPO occupancy and the plasma concentration of ONO-2952 and to investigate the safety and tolerability of ONO-2952 in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy non-smoking male or female subjects (18-55 inclusive)\n* Body mass index (BMI) of 19-35 kg/m2 (inclusive)\n* For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception\n\nExclusion Criteria:\n\n* History or presence of clinically significant disease'}, 'identificationModule': {'nctId': 'NCT01613703', 'briefTitle': 'ONO-2952 Single-dose PET Study in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'Open-Label, Single-Center, Single Dose Positron Emission Topography (PET) Using [11C]PBR28 to Evaluate Brain Translocator Protein 18KDa (TSPO) Occupancy of ONO-2952 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'ONO-2952POU003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'interventionNames': ['Drug: ONO-2952']}], 'interventions': [{'name': 'ONO-2952', 'type': 'DRUG', 'description': '1 mg to 200 mg QD at a single descending dose', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15218', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pittsburgh Clinical Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Ono Pharma USA, Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharma USA Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}