Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2026-01-08 @ 8:25 AM
Study NCT ID:
NCT02307461
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2014-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence of Duvelisib and Food Effect on Pharmacokinetics of IPI-145
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C586691', 'term': 'duvelisib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2014-11-18', 'studyFirstSubmitQcDate': '2014-12-01', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of bioequivalence of the IPI-145 test and reference formulations', 'timeFrame': '24 Hours'}, {'measure': 'Pharmacokinetic Parameter (AUClast ) of IPI-145', 'timeFrame': 'Over 24 hours'}, {'measure': 'Pharmacokinetic Parameter (AUCinf ) of IPI-145', 'timeFrame': 'Over 24 hours'}, {'measure': 'Pharmacokinetic Parameter (Cmax) of IPI-145', 'timeFrame': 'Over 24 hours'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events following administration of IPI-145', 'timeFrame': '7 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase 1', 'Bioequivalence', 'Pharmacokinetics', 'Food', 'Healthy Adult'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145', 'detailedDescription': 'This Phase 1, randomized, open-label study of IPI-145 will be conducted in 2 parts.\n\nPart 1 will be conducted in 2 cohorts. Cohort 1 will consist of 32 healthy subjects, and Cohort 2 will consist of 52 healthy subjects. Subjects in each cohort will receive 2 doses of IPI under fasted conditions in a 2-period, 2-sequence crossover design. Dosing in Period 1 and Period 2 will be separated by at least 7 days.\n\nPart 2 is a 2-period, 2-sequence crossover design to assess the effect of a high-fat meal on the PK of the IPI-145 in 20 subjects. Subjects will receive single oral doses under fed (high-fat meal) and fasted conditions, separated by at least 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women of non-child bearing potential between 18-50 years of age\n* Body Mass Index (BMI): 18.0 - 32.0 kg/m2.\n* Healthy subjects: in good health, determined by no clinically significant findings from clinical evaluations\n* Provided written informed consent prior to any study specific procedures\n\nExclusion Criteria:\n\n* Women of childbearing potential\n* Healthy subjects: positive screening test for hepatitis B surface antigen, hepatitis C antibody, or HIV-1/HIV-2 antibodies\n* ECG at screening showing QTcF ≥ 450 msec\n* Evidence of clinically significant medical conditions\n* History of gastrointestinal disease or surgery that may affect drug absorption\n* Positive T-Spot (tuberculosis)TB test at screening\n* Any active infection at the time of screening or admission'}, 'identificationModule': {'nctId': 'NCT02307461', 'briefTitle': 'Bioequivalence of Duvelisib and Food Effect on Pharmacokinetics of IPI-145', 'organization': {'class': 'INDUSTRY', 'fullName': 'SecuraBio'}, 'officialTitle': 'A Phase 1, Open-label, 2-Part Study to Evaluate the Bioequivalence of the Duvelisib Marker-Image Formulation to the Duvelisib Clinical-Trial Formulation and to Assess the Effect of Food on the Pharmacokinetics of IP Duvelisib in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'IPI-145-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 1', 'description': 'IPI-145 test formulation (capsule) high single dose and IPI-145 reference formulation (capsule) high single dose', 'interventionNames': ['Drug: IPI-145 (duvelisib)']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 2', 'description': 'IPI-145 test formulation (capsule) low single dose and IPI-145 reference formulation (capsule) low single dose', 'interventionNames': ['Drug: IPI-145']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Cohort 3', 'description': 'IPI-145 test formulation (capsule) high single dose administered under fasted and fed conditions', 'interventionNames': ['Drug: IPI-145']}], 'interventions': [{'name': 'IPI-145 (duvelisib)', 'type': 'DRUG', 'description': 'High single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) high single oral dose', 'armGroupLabels': ['Part 1 Cohort 1']}, {'name': 'IPI-145', 'type': 'DRUG', 'description': 'Low single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) low single oral dose', 'armGroupLabels': ['Part 1 Cohort 2']}, {'name': 'IPI-145', 'type': 'DRUG', 'description': 'High single oral dose IPI-145 test formulation (capsule) with a high-fat meal and without food', 'armGroupLabels': ['Part 2 Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}], 'overallOfficials': [{'name': 'Hagop Youssoufian, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Verastem, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SecuraBio', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}