Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-05 @ 5:21 PM
Study NCT ID:
NCT02390492
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2015-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Bioavailability and Pharmacokinetic Study of [14C]-Ipatasertib Single Oral and Intravenous Doses in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2015-03-11', 'studyFirstSubmitQcDate': '2015-03-16', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): apparent terminal elimination half-life', 'timeFrame': 'Period 2: Approximately 2 weeks'}, {'measure': 'Pharmacokinetics of ipatasertib (oral): apparent total clearance (CL/F)', 'timeFrame': 'Period 2: Approximately 2 weeks'}, {'measure': 'Pharmacokinetics of ipatasertib (oral): apparent volume of distribution (Vz/F)', 'timeFrame': 'Period 2: Approximately 2 weeks'}, {'measure': 'Elimination and pharmacokinetics: Total radioactivity concentration in whole blood, plasma, urine, and feces', 'timeFrame': 'Period 2: Approximately 2 weeks'}, {'measure': 'Bioavailability: Absolute bioavailability of ipatasertib (area under the concentration-time curve)', 'timeFrame': 'Period 1: Approximately 4 days'}, {'measure': 'Mass balance', 'timeFrame': 'Period 2: Approximately 2 weeks'}, {'measure': 'Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): maximum observed concentration (Cmax)', 'timeFrame': 'Period 2: Approximately 2 weeks'}, {'measure': 'Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): time to maximum observed concentration (Tmax)', 'timeFrame': 'Period 2: Approximately 2 weeks'}, {'measure': 'Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): area under the concentration-time curve from Hour 0 to the last measurable concentration (AUC0-t)', 'timeFrame': 'Period 2: Approximately 2 weeks'}, {'measure': 'Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): area under the concentration-time curve extrapolated to infinity (AUC0-inf)', 'timeFrame': 'Period 2: Approximately 2 weeks'}, {'measure': 'Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): apparent terminal elimination rate constant', 'timeFrame': 'Period 2: Approximately 2 weeks'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of ipatasertib (oral and IV): terminal elimination rate constant adjusted for oral bioavailability as applicable', 'timeFrame': 'Period 1: Approximately 4 days'}, {'measure': 'Pharmacokinetics of ipatasertib (oral and IV): terminal elimination half-life adjusted for oral bioavailability as applicable', 'timeFrame': 'Period 1: Approximately 4 days'}, {'measure': 'Pharmacokinetics of ipatasertib (oral and IV): total clearance adjusted for oral bioavailability as applicable', 'timeFrame': 'Period 1: Approximately 4 days'}, {'measure': 'Pharmacokinetics of ipatasertib (oral and IV): volume of distribution adjusted for oral bioavailability as applicable', 'timeFrame': 'Period 1: Approximately 4 days'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'Approximately 4 weeks'}, {'measure': 'Elimination and pharmacokinetics: Metabolite concentration(s) in plasma, urine, and feces', 'timeFrame': 'Period 2: Approximately 2 weeks'}, {'measure': 'Pharmacokinetics of ipatasertib (oral and IV): Cmax', 'timeFrame': 'Period 1: Approximately 4 days'}, {'measure': 'Pharmacokinetics of ipatasertib (oral and IV): Tmax', 'timeFrame': 'Period 1: Approximately 4 days'}, {'measure': 'Pharmacokinetics of ipatasertib (oral and IV): AUC0-t', 'timeFrame': 'Period 1: Approximately 4 days'}, {'measure': 'Pharmacokinetics of ipatasertib (oral and IV): AUC0-inf', 'timeFrame': 'Period 1: Approximately 4 days'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This 2-period, open-label, nonrandomized study will be conducted to determine the absolute bioavailability as well as the absorption, metabolism, and excretion of ipatasertib and its metabolite(s). Healthy male participants will receive a single 200-mg oral dose of ipatasertib followed 1 hour later by an 80-mcg/800-nCi intravenous dose of \\[14C\\]-ipatasertib. After a 4-day observation period and 10-day washout, participants will receive a single 200-mg/100-mcCi oral dose of \\[14C\\]-ipatasertib with subsequent data collection for an additional 7 to 14 days until discharge criteria are met.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteers 18 to 55 years of age, inclusive\n* Body mass index (BMI) 18 to 32 kg/m2, inclusive\n\nExclusion Criteria:\n\n* Females\n* Clinically significant findings from medical history or screening evaluations\n* Recent participation in any other investigational drug study or biologic agent study, or receipt of a previous radiolabeled investigational drug within 6 months prior to check-in\n* Significant radiation exposure within 12 months prior to check-in'}, 'identificationModule': {'nctId': 'NCT02390492', 'briefTitle': 'A Phase I Bioavailability and Pharmacokinetic Study of [14C]-Ipatasertib Single Oral and Intravenous Doses in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Ipatasertib (GDC-0068) Following a Single Oral Dose and to Investigate the Absolute Bioavailability Following Single Oral and Intravenous Doses in a Single Cohort of Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'GP29067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ipatasertib/[14C]-ipatasertib', 'interventionNames': ['Drug: Period 1 treatment', 'Drug: Period 2 treatment']}], 'interventions': [{'name': 'Period 1 treatment', 'type': 'DRUG', 'description': '200 mg oral ipatasertib followed 1 hour later by 80-mcg/800-nCi intravenous \\[14C\\]-ipatasertib on Day 1 of study', 'armGroupLabels': ['Ipatasertib/[14C]-ipatasertib']}, {'name': 'Period 2 treatment', 'type': 'DRUG', 'description': '200-mg/100-mcCi oral \\[14C\\]-ipatasertib on Day 15 of study', 'armGroupLabels': ['Ipatasertib/[14C]-ipatasertib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}