Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT02621957
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2015-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000606997', 'term': '3-(4-(2-(2-chloro-4-fluorophenyl)-1-(1H-indazol-5-yl)but-1-en-1-yl)phenyl)acrylic acid'}, {'id': 'D017035', 'term': 'Pravastatin'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2015-12-02', 'studyFirstSubmitQcDate': '2015-12-02', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax) of Pravastatin', 'timeFrame': 'Days 1-3 (Period 1) and Days 7-10 (Period 2)'}, {'measure': 'Time to Maximum Concentration (Tmax) of Pravastatin', 'timeFrame': 'Days 1-3 (Period 1) and Days 7-10 (Period 2)'}, {'measure': 'Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Pravastatin', 'timeFrame': 'Days 1-3 (Period 1) and Days 7-10 (Period 2)'}, {'measure': 'Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Pravastatin', 'timeFrame': 'Days 1-3 (Period 1) and Days 7-10 (Period 2)'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of Pravastatin', 'timeFrame': 'Days 1-3 (Period 1) and Days 7-10 (Period 2)'}, {'measure': 'Apparent Clearance (CL/F) of Pravastatin', 'timeFrame': 'Days 1-3 (Period 1) and Days 7-10 (Period 2)'}, {'measure': 'Apparent Terminal Elimination Rate Constant (lambda z) of Pravastatin', 'timeFrame': 'Days 1-3 (Period 1) and Days 7-10 (Period 2)'}, {'measure': 'Apparent Terminal Elimination Half-Life (t1/2) of Pravastatin', 'timeFrame': 'Days 1-3 (Period 1) and Days 7-10 (Period 2)'}, {'measure': 'Amount of Pravastatin Excreted in Urine (Ae)', 'timeFrame': 'Day 1 (Period 1) and Day 7 (Period 2)'}, {'measure': 'Renal Clearance (CLR) of Pravastatin', 'timeFrame': 'Day 1 (Period 1) and Day 7 (Period 2)'}, {'measure': 'Percentage of Pravastatin Excreted in Urine (%Excreted)', 'timeFrame': 'Day 1 (Period 1) and Day 7 (Period 2)'}, {'measure': 'Plasma Concentrations of Pravastatin', 'timeFrame': 'Days 1-3 (Period 1) and Days 7-10 (Period 2)'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax) of GDC-0810', 'timeFrame': 'Days 7-10 (Period 2)'}, {'measure': 'Time to Maximum Concentration (Tmax) of GDC-0810', 'timeFrame': 'Days 7-10 (Period 2)'}, {'measure': 'Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of GDC-0810', 'timeFrame': 'Days 7-10 (Period 2)'}, {'measure': 'Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of GDC-0810', 'timeFrame': 'Days 7-10 (Period 2)'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of GDC-0810', 'timeFrame': 'Days 7-10 (Period 2)'}, {'measure': 'Apparent Clearance (CL/F) of GDC-0810', 'timeFrame': 'Days 7-10 (Period 2)'}, {'measure': 'Apparent Terminal Elimination Rate Constant (lambda z) of GDC-0810', 'timeFrame': 'Days 7-10 (Period 2)'}, {'measure': 'Apparent Terminal Elimination Half-Life (t1/2) of GDC-0810', 'timeFrame': 'Days 7-10 (Period 2)'}, {'measure': 'Amount of GDC-0810 Excreted in Urine (Ae)', 'timeFrame': 'Day 7 (Period 2)'}, {'measure': 'Renal Clearance (CLr) of GDC-0810', 'timeFrame': 'Day 7 (Period 2)'}, {'measure': 'Percentage of GDC-0810 Excreted in Urine (%Excreted)', 'timeFrame': 'Day 7 (Period 2)'}, {'measure': 'Percentage of Participants with Adverse Events (AEs)', 'timeFrame': 'From baseline to study completion up to Day 28'}, {'measure': 'Percentage of Participants with Serious Adverse Events (SAEs)', 'timeFrame': 'From baseline to study completion up to Day 28'}, {'measure': 'Percentage of Participants with Clinically Significant Changes in Safety Measurements, Including Vital Signs, Electrocardiograms (ECGs), Physical Examination Findings and Clinical Laboratory Results.', 'timeFrame': 'From baseline to study completion up to Day 28'}, {'measure': 'Plasma Concentrations of GDC-0810', 'timeFrame': 'Days 7-10 (Period 2)'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study is to assess the pharmacokinetics (PK) of a single dose of pravastatin with and without concomitant GDC-0810 administration in healthy female subjects of non-childbearing potential. During Period 1 (Day -1 to Day 4) PK parameters of pravastatin will be determined in the absence of GDC-0810. During Period 2 (Days 5-28) PK parameters of pravastatin will be determined in the presence of GDC-0810.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects between 18 and 65 years of age, inclusive.\n* Female subjects of non-childbearing potential including non-pregnant, non-lactating, and either postmenopausal or surgically sterile for at least 45 days post procedure.\n* Within BMI range 18.5 to \\</= 29.9 kg/m\\^2, inclusive.\n* In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations.\n* Receive an explanation of the mandatory pharmacogenomic (PgX) component of the study.\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* Previous history of adverse reaction to statins.\n* Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to Check-in (Day -1) in Period 1.\n* Use of systemic hormone replacement therapy within 1 year prior to Check-in (Day -1).\n* History of use of tamoxifen, aromatase inhibitor or any other endocrine agent for treatment of breast cancer.\n* Female subject is pregnant lactating, or breast feeding.'}, 'identificationModule': {'nctId': 'NCT02621957', 'briefTitle': 'Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase 1, Open-Label Study to Evaluate the Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential', 'orgStudyIdInfo': {'id': 'GP29825'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Female Healthy Volunteers', 'description': 'Healthy volunteer female subjects of non-childbearing potential will be administered pravastatin once on Day 1 during Period 1 (Day -1 to Day 4). During Period 2 (Days 5-28) GDC-0810 will be administered daily on Days 5-8. Pravastatin will be co-administered on Day 7.', 'interventionNames': ['Drug: GDC-0810', 'Drug: Pravastatin']}], 'interventions': [{'name': 'GDC-0810', 'type': 'DRUG', 'otherNames': ['ARN-810'], 'description': 'During Period 2 subjects will be administered an oral 600 mg dose GDC-0810 daily beginning on Day 5 for 4 consecutive days (from Days 5 to 8, inclusive).', 'armGroupLabels': ['Female Healthy Volunteers']}, {'name': 'Pravastatin', 'type': 'DRUG', 'otherNames': ['Pravachol'], 'description': 'Subjects will receive a single oral dose of 10 mg pravastatin on Day 1 in Period 1 and Day 7 in Period 2.', 'armGroupLabels': ['Female Healthy Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}