Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-03-01 @ 1:25 PM
Study NCT ID:
NCT00991718
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2009-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'interventionBrowseModule': {'meshes': [{'id': 'C538724', 'term': 'HhAntag691'}, {'id': 'D011356', 'term': 'Product Labeling'}], 'ancestors': [{'id': 'D019064', 'term': 'Product Packaging'}, {'id': 'D007221', 'term': 'Industry'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-23', 'studyFirstSubmitDate': '2009-10-06', 'studyFirstSubmitQcDate': '2009-10-07', 'lastUpdatePostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK (Max observed and time to max plasma concentrations, area under the plasma concentration-time curve, absolute bioavailability, total plasma clearance, vol of dist, plasma terminal phase half-life, cumulative % excretion in urine and feces [Part B])', 'timeFrame': 'Until study discontinuation'}], 'secondaryOutcomes': [{'measure': 'Safety outcome measures (incidence, nature, and severity of adverse events; change in clinical laboratory results; change in vital signs; change in electrocardiogram [ECG]; and change in physical examination findings)', 'timeFrame': 'Until study discontinuation'}]}, 'conditionsModule': {'keywords': ['GDC0449'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is an open-label, Phase I, single-center, single-dose administration study to determine the absolute bioavailability, clearance, and volume of distribution of GDC-0449 (Part A) and to determine the routes of excretion and extent of metabolism of GDC-0449 (Part B). Parts A and B will be conducted sequentially, with ≥ 7 days between dosing the sixth subject in Part A and dosing the first subject in Part B. In each part, 6 healthy female subjects of non-childbearing potential, between 18 and 65 years of age (inclusive), will be dosed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* Female\n* Non-childbearing potential\n* Body mass index (BMI) between 18 and 32 kg/m\\^2, inclusive\n* In good health, determined by no clinically significant findings on physical examination, medical history, 12-lead ECG, and vital signs\n* Negative test for drugs of abuse at screening (does not include alcohol) and at admission to the clinical research facility (does include alcohol)\n\nExclusion Criteria\n\n* History or clinical manifestations of clinically significant metabolic, hepatic, renal, hematologic, pulmonary, cardiovascular, endocrine, gastrointestinal (including gastric or duodenal ulcers), urologic, neurologic, inflammatory, or psychiatric disorders, or cancer\n* History of symptomatic hypotension, idiopathic orthostatic hypotension, or other autonomous-failure syndromes\n* History of severe physical injury, direct impact trauma, or neurological trauma within 6 months prior to Day -1\n* History of stomach or intestinal surgery, stomach disease, or resection that would potentially alter absorption and/or excretion of orally administered drugs (appendectomy, hernia repair, and/or cholecystectomy are allowed)\n* History of alcoholism, drug abuse, or drug addiction (including soft drugs like cannabis products)\n* Use of any prescription medications/products, including known enzyme-inducing/inhibiting agents, over-the-counter medication, or other non-prescription preparations (including supplements, vitamins, minerals, phytotherapeutic/herbal/ plant-derived preparations, the tryptophans, and St. John's wort or other hypericum perforatum-containing substance) within 2 weeks prior to Day -1, with the exception of hormone-replacement therapy\n* Participation in any other investigational drug study in which receipt of an investigational study drug occurred within 60 days prior to Day -1 or within 5 times the elimination half-life of the respective drug; participation in a trial involving administration of \\^1\\^4C-radiolabeled compound(s) within 6 months prior to Day -1; participation in more than two other drug trials within 1 year prior to Day -1\n* Receipt of any vaccination or immunization within 1 month prior to Day -1\n* Use of any nicotine-containing or nicotine-replacement products within 6 months prior to Day -1\n* Consumption of alcohol or methylxanthine-containing beverages or food\n* Receipt of blood products within 2 months prior to Day -1\n* Donation of \\> 100 mL of blood within 60 days prior to Day -1; donation of \\> 1.0 litres of blood within 10 months prior to Day -1\n* Irregular defecation pattern, i.e., less than once per 2 days within 6 months prior to Day -1; acute constipation problems within 3 weeks prior to Day -1 (Part B subjects only)\n* Poor peripheral venous access"}, 'identificationModule': {'nctId': 'NCT00991718', 'briefTitle': 'A Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase I, Open-Label Absorption, Distribution, Metabolism, and Excretion (ADME) Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential', 'orgStudyIdInfo': {'id': 'SHH4683g'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'On Day 1, subjects received a single oral dose of non-labeled GDC-0449 and a single IV tracer dose of 14C-GDC-0449.', 'interventionNames': ['Drug: GDC-0449 oral capsules (non-labeled)', 'Drug: GDC-0449 IV injection (labeled)']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'On Day 1, subjects received a single oral dose of 14C-GDC-0449.', 'interventionNames': ['Drug: CDC-0449 oral suspension (labeled)']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'On Days 1-7, subjects received a single oral dose of non-labeled GDC-0449. On Day 7, subjects also received a single IV tracer dose of 14C-GDC-0449.', 'interventionNames': ['Drug: GDC-0449 oral capsules (non-labeled)', 'Drug: GDC-0449 IV injection (labeled)']}, {'type': 'EXPERIMENTAL', 'label': 'D', 'description': 'On Days 1-6, subjects received a single oral dose of non-labeled GDC-0449. On Day 7, subjects received a single oral dose of 14C-GDC-0449.', 'interventionNames': ['Drug: GDC-0449 oral capsules (non-labeled)', 'Drug: CDC-0449 oral suspension (labeled)']}], 'interventions': [{'name': 'GDC-0449 oral capsules (non-labeled)', 'type': 'DRUG', 'description': '150 mg oral capsule', 'armGroupLabels': ['A', 'C', 'D']}, {'name': 'GDC-0449 IV injection (labeled)', 'type': 'DRUG', 'description': '10 mcg (in 2 mL) IV dose of 14C-GDC-0449', 'armGroupLabels': ['A', 'C']}, {'name': 'CDC-0449 oral suspension (labeled)', 'type': 'DRUG', 'description': '30-mL oral suspension containing 6.5 mcg 14CGDC-0449 and 150 mg GDC-0449', 'armGroupLabels': ['B', 'D']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jennifer Low, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}