Ignite Creation Date:
2025-12-17 @ 1:41 PM
Ignite Modification Date:
2025-12-23 @ 10:24 PM
Study NCT ID:
NCT01836861
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2013-04-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IPI-145 ADME and Absolute Bioavailability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'interventionBrowseModule': {'meshes': [{'id': 'C586691', 'term': 'duvelisib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2013-04-01', 'studyFirstSubmitQcDate': '2013-04-17', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK parameters (AUC) of IPI-145 in plasma', 'timeFrame': 'over 48 hours'}, {'measure': 'PK parameters (AUC) and radioactivity excreted in urine and feces', 'timeFrame': 'over 144 hours'}, {'measure': 'PK parameters (Cmax) of IPI-145 in plasma', 'timeFrame': 'over 48 hours'}, {'measure': 'PK parameters (t1/2) of IPI-145 in plasma', 'timeFrame': 'over 48 hours'}, {'measure': 'PK parameters (Cmax) and radioactivity excreted in urine and feces', 'timeFrame': 'over 144 hours'}, {'measure': 'PK parameters (t1/2) and radioactivity excreted in urine and feces', 'timeFrame': 'over 144 hours'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events following a single dose administration of IPI-145', 'timeFrame': 'over 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase I', 'healthy male volunteers', 'ADME', 'Bioavailability', 'PI3K inhibitor', 'Absorption', 'Distribution', 'Metabolism', 'Excretion', 'safety'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME) and absolute bioavailability study in 6 healthy adult male subjects.', 'detailedDescription': 'In Period 1, subjects will receive a single oral dose of 25 mg IPI-145, followed by a 15-minute IV infusion of approximately 2.8 μg 14C-IPI-145 containing 14.8 kBq of radioactivity.\n\nIn Period 2, the same subjects will receive a single dose of 25 mg 14C-IPI-145 as an oral suspension, containing approximately 3.15 MBq of radioactivity.\n\nThere will be a washout period of at least 14 days between Period 1 and Period 2.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males, between 18 and 45 years of age, inclusive Body Mass Index (BMI) : 18.0-30.0 kg/m2\n* In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs\n* Provision of signed and dated, written informed consent prior to any study specific procedures\n\nExclusion Criteria:\n\n* Evidence of clinically significant medical conditions\n* History of gastrointestinal surgery that may affect drug absorption\n* Positive or indeterminate QuantiFERON-TB Gold test at screening\n* Any active infection at the time of screening or admission\n* Participation in another ADME study with a radiation burden \\>0.1 mSv in the period of 1 year before screening\n* Irregular defecation pattern (less than once per 2 days)'}, 'identificationModule': {'nctId': 'NCT01836861', 'briefTitle': 'IPI-145 ADME and Absolute Bioavailability Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'SecuraBio'}, 'officialTitle': 'A Phase 1, Open-Label Study of the Absorption, Distribution, Metabolism and Excretion of 14C-Labeled IPI-145 and the Absolute Bioavailability of IPI-145 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'IPI-145-05'}, 'secondaryIdInfos': [{'id': '2012-005425-75', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IPI-145 and [14C] IPI-145', 'interventionNames': ['Drug: IPI-145']}], 'interventions': [{'name': 'IPI-145', 'type': 'DRUG', 'description': 'Intravenous infusion: approximately 2.8 μg IPI-145 containing 14.8 kBq of radioactivity; Oral suspension: 25 mg IPI-145 containing approximately 3.15 MBq of radioactivity; Oral capsule: 25 mg IPI-145', 'armGroupLabels': ['IPI-145 and [14C] IPI-145']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zuidlaren', 'country': 'Netherlands', 'facility': 'Pharmaceuticals Research Association (PRA)', 'geoPoint': {'lat': 53.09417, 'lon': 6.68194}}], 'overallOfficials': [{'name': 'Hagop Youssoufian, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Verastem, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SecuraBio', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}