Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-25 @ 7:51 PM
Study NCT ID:
NCT07226635
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2025-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Interaction Trial of Clofutriben With Midazolam and Prednisolone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-11-06', 'studyFirstSubmitQcDate': '2025-11-07', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of midazolam.', 'timeFrame': '24 hours from dose', 'description': 'It will be concluded that there is no relevant interaction of clofutriben on midazolam if the 90% CIs for the Cmax ratios (midazolam + clofutriben)/midazolam alone) are contained within the \\[80%, 125%\\] interval.'}, {'measure': 'AUC0-t of midazolam', 'timeFrame': '24 hours from dose', 'description': ': It will be concluded that there is no relevant interaction of clofutriben on midazolam if the 90% CIs for the AUC0-t (midazolam + clofutriben)/midazolam alone) are contained within the \\[80%, 125%\\] interval.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'Drug: 2 single oral doses of midazolam, 2 single oral doses of prednisolone , and clofutriben once daily for 16 days.', 'detailedDescription': 'Approximately 16 healthy male and female participants will be enrolled at a single center in the US. Each participant will receive 2 single oral doses of midazolam , 2 single oral doses of prednisolone, and clofutriben once daily for 16 days. On each day that midazolam is administered, blood samples for midazolam analysis in plasma will be collected for 24 hours. On each day that prednisolone is administered, blood samples for prednisolone, prednisone, and 6β-hydroxyprednisolone analyses in plasma will be collected for 24 hours.\n\nBlood samples for clofutriben and metabolite (AS2570469) analyses in plasma will be collected for 24 hours after the first dose and during 2 intervals at steady state. Blood samples for cortisol and cortisone analyses will be collected for 24 hours after administration of prednisolone, clofutriben, and both trial interventions together, and prior to dosing of either trial intervention. Urine will be collected for analysis of clofutriben, prednisolone, and metabolites. Feces will be collected for analysis of clofutriben and metabolites. Safety and tolerability will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female participants aged 18 to 75 years of age,\n* Body mass index of 18 to 35 kg/m2,\n* Taking no medications,\n* Are considered by the investigator to be in good general health.\n\nExclusion Criteria:\n\n* In the opinion of the investigator, the participant is not suitable for entry into the trial or has any contraindication to midazolam or prednisolone.'}, 'identificationModule': {'nctId': 'NCT07226635', 'acronym': 'DDI', 'briefTitle': 'Pharmacokinetic Interaction Trial of Clofutriben With Midazolam and Prednisolone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sparrow Pharmaceuticals'}, 'officialTitle': 'Pharmacokinetic Interaction Trial of Clofutriben With Midazolam and Prednisolone', 'orgStudyIdInfo': {'id': 'SPI-62-CL-1004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: midazolam', 'description': 'Drug: 2 single oral doses of midazolam', 'interventionNames': ['Drug: midazolam']}, {'type': 'EXPERIMENTAL', 'label': '2 single oral doses of prednisolone', 'description': '2 single oral doses of prednisolone', 'interventionNames': ['Drug: 2 single oral doses of prednisolone']}, {'type': 'EXPERIMENTAL', 'label': 'clofutriben once daily for 16 days', 'description': 'clofutriben once daily for 16 days', 'interventionNames': ['Drug: clofutriben once daily for 16 days']}], 'interventions': [{'name': 'midazolam', 'type': 'DRUG', 'description': 'Drug: 2 single oral doses of midazolam ,', 'armGroupLabels': ['Experimental: midazolam']}, {'name': 'clofutriben once daily for 16 days', 'type': 'DRUG', 'description': 'clofutriben once daily for 16 days', 'armGroupLabels': ['clofutriben once daily for 16 days']}, {'name': '2 single oral doses of prednisolone', 'type': 'DRUG', 'description': '2 single oral doses of prednisolone', 'armGroupLabels': ['2 single oral doses of prednisolone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'PPD Austin Research Unit', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sparrow Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}