Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-29 @ 2:45 AM
Study NCT ID:
NCT01474668
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0941 Following Single Oral Dose Administration in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C532162', 'term': '2-(1H-indazol-4-yl)-6-(4-methanesulfonylpiperazin-1-ylmethyl)-4-morpholin-4-ylthieno(3,2-d)pyrimidine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-11-16', 'studyFirstSubmitQcDate': '2011-11-16', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent terminal elimination half-life', 'timeFrame': 'up to approximately 6 weeks or early study discontinuation'}, {'measure': 'Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent terminal phase elimination rate constant', 'timeFrame': 'up to approximately 6 weeks or early study discontinuation'}, {'measure': 'Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent total clearance', 'timeFrame': 'up to approximately 6 weeks or early study discontinuation'}, {'measure': 'Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent volume of distribution', 'timeFrame': 'up to approximately 6 weeks or early study discontinuation'}, {'measure': 'Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: area under the concentration-time curve extrapolated to infinity', 'timeFrame': 'up to approximately 6 weeks or early study discontinuation'}, {'measure': 'Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: area under the concentration-time curve from Hour 0 to the last measurable concentration', 'timeFrame': 'up to approximately 6 weeks or early study discontinuation'}, {'measure': 'Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: maximum observed concentration', 'timeFrame': 'up to approximately 6 weeks or early study discontinuation'}, {'measure': 'Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: time to maximum concentration', 'timeFrame': 'up to approximately 6 weeks or early study discontinuation'}], 'secondaryOutcomes': [{'measure': 'Amount of drug excreted in the feces over the sampling interval', 'timeFrame': 'up to approximately 6 weeks or early study discontinuation'}, {'measure': 'Percent excreted in feces', 'timeFrame': 'up to approximately 6 weeks or early study discontinuation'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This study will be an open-label, non-randomized, absorption, metabolism, and excretion study of \\[14C\\]-GDC 0941 administered as an oral dose to 6 healthy male subjects following at least a 10-hour fast from food (not including water).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Within BMI range 18.5 to 29.9 kg/m2, inclusive\n* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs\n* Clinical laboratory evaluations within the reference range for the test laboratory\n* Negative test for selected drugs of abuse at Screening and at Check-in\n* Negative hepatitis panel (including hepatitis B surface antigen \\[HBsAg\\], hepatitis C virus antibody \\[anti-HCV\\]) and negative HIV antibody screens\n* Subjects will either be sterile or agree to use an approved form of contraception from Check-in until 45 days following Study Completion/ET\n* Agree not to donate sperm from Screening throughout the study period and for at least 3 months (90 days) after the last dose of study drug\n* A minimum of 1 to 2 bowel movements per day\n\nExclusion Criteria:\n\n* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder\n* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance\n* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (except that appendectomy and hernia repair will be allowed)\n* History of Gilbert's Syndrome\n* History of diabetes mellitus and/or elevated fasting glucose at baseline\n* History or presence of an abnormal ECG\n* History of alcoholism or drug addiction within 1 year prior to Check-in\n* Participation in more than one other radiolabeled investigational study drug trial within 12 months prior to Check-in. The previous radiolabeled study drug must have been received more than 6 months prior to Check-in for this study and the total exposure from this study and the previous study will be within the recommended levels considered safe\n* Exposure to significant radiation within 12 months prior to Check-in\n* Use of any tobacco-containing or nicotine-containing products within 6 months prior to Check-in or positive urine drug screen for cotinine\n* Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to Check-in\n* Use of any prescription medications/products within 14 days prior to Check-in, unless deemed acceptable by the Investigator\n* Use of any over-the-counter (OTC), non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations) within 7 days prior to Check-in\n* Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours prior to Check-in, unless deemed acceptable by the Investigator\n* Poor peripheral venous access\n* Donation of blood from 30 days prior to Screening or of plasma from 2 weeks prior to Screening\n* Receipt of blood products within 2 months prior to Check-in\n* Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study"}, 'identificationModule': {'nctId': 'NCT01474668', 'briefTitle': 'Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0941 Following Single Oral Dose Administration in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of [14c]-GDC-0941 Following Single Oral Dose Administration in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'GP27917'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Experimental', 'interventionNames': ['Drug: GDC-0941']}], 'interventions': [{'name': 'GDC-0941', 'type': 'DRUG', 'description': 'Single oral dose\\\\n \\\\n\\\\n\\\\n\\\\n', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704-2523', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Scott Holden, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}