Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-04 @ 7:13 AM
Study NCT ID:
NCT01967966
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2013-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioavailability and Pharmacokinetic Study of GDC-0032 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C582924', 'term': '2-(3-(2-(1-isopropyl-3-methyl-1H-1,2-4-triazol-5-yl)-5,6-dihydrobenzo(f)imidazo(1,2-d)(1,4)oxazepin-9-yl)-1H-pyrazol-1-yl)-2-methylpropanamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2013-10-18', 'studyFirstSubmitQcDate': '2013-10-18', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioavailability: Absolute bioavailability of GDC-0032 (Area under the concentration-time curve [AUC])', 'timeFrame': 'Days 1 to 11'}, {'measure': 'Elimination & PK: Amount of drug excreted in urine/feces over the sampling interval', 'timeFrame': 'Days 1 to 22'}, {'measure': 'Elimination & PK: Maximum concentration (Cmax) of GDC-0032', 'timeFrame': 'Days 1 to 22'}, {'measure': 'Elimination & PK: Area under the concentration-time curve (AUC)', 'timeFrame': 'Days 1 to 22'}, {'measure': 'Elimination & PK: Total radioactivity concentrations in whole blood, plasma, urine, and feces.', 'timeFrame': 'Days 1 to 22'}], 'secondaryOutcomes': [{'measure': 'Elimination & PK: Metabolite identification in plasma, urine, & feces', 'timeFrame': 'Days 1 to 22'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': '38 to 49 days'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This 2-arm, open-label, non-randomized study will investigate the absolute bioavailability, pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety in healthy volunteers. Patients will receive either a single oral dose of GDC-0032 followed by a 14C-labeled IV dose of GDC-0032 or a single oral dose of 14C-labelled GDC-0032.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) 18 to 32 kg/m2, inclusive;\n* Healthy, as judged by physician from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations;\n* Agree to use effective contraceptive methods as defined by protocol;\n* Negative hepatitis panel and HIV screen;\n* Sufficient bowel movements (minimum of 1 per day).\n\nExclusion Criteria:\n\n* History or clinical manifestation of: any major medical disorders; any food/drug/substance allergies;\n* History of stomach or intestinal surgery or resection except for appendectomy and/or hernia repair;\n* History of alcoholism or drug addiction within 1 year prior to drug administration;\n* Tobacco or nicotine use within 6 months prior to study start;\n* Chronic use of gastric acid inhibitors within 6 months of study start or use of gastric acid inhibitors and/or antacids within 1 month prior to drug administration;\n* Evidence of malabsorption syndrome or other condition interfering with gastrointestinal absorption;\n* Inability or unwillingness to swallow capsules;\n* Participation in a drug study in which a drug was administered within 30 days prior to study start;\n* Participation in more than one radiolabeled drug study within 12 months preceding drug administration. The previous radiolabeled study drug must have been received more than 6 months prior to this study, and the total exposure from this study and the previous study is less than 5000 mrem whole body annual exposure;\n* Exposure to significant radiation within 12 months prior to study start.'}, 'identificationModule': {'nctId': 'NCT01967966', 'briefTitle': 'A Bioavailability and Pharmacokinetic Study of GDC-0032 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A PHASE 1 STUDY TO INVESTIGATE THE ABSOLUTE BIOAVAILABILITY OF GDC-0032 AND THE ABSORPTION, METABOLISM, AND EXCRETION OF [14C]-GDC-0032 IN HEALTHY MALE SUBJECTS', 'orgStudyIdInfo': {'id': 'GP28755'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bioavailability', 'interventionNames': ['Drug: GDC-0032']}, {'type': 'EXPERIMENTAL', 'label': 'Elimination & PK', 'interventionNames': ['Drug: GDC-0032']}], 'interventions': [{'name': 'GDC-0032', 'type': 'DRUG', 'description': 'Single oral dose', 'armGroupLabels': ['Bioavailability', 'Elimination & PK']}, {'name': 'GDC-0032', 'type': 'DRUG', 'description': 'Single IV dose', 'armGroupLabels': ['Bioavailability']}]}, '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': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}