Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-07 @ 6:43 AM
Study NCT ID:
NCT03290703
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2017-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619415', 'term': 'fenebrutinib'}, {'id': 'D064750', 'term': 'Rabeprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2017-09-19', 'studyFirstSubmitQcDate': '2017-09-19', 'lastUpdatePostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of GDC-0853', 'timeFrame': 'Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of GDC-0853', 'timeFrame': 'Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part'}, {'measure': 'Area Under the Curve From Time Zero to Last Measurable Concentration [AUC (0-t)] of GDC-0853', 'timeFrame': 'Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of GDC-0853', 'timeFrame': 'Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part'}, {'measure': 'Extrapolated Area Under the Curve (AUC Percent [%] Extrap) of GDC-0853', 'timeFrame': 'Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part'}, {'measure': 'Apparent Terminal Elimination Rate Constant of GDC-0853', 'timeFrame': 'Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of GDC-0853', 'timeFrame': 'Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part'}, {'measure': 'Apparent Oral Clearance (CL/F) of GDC-0853', 'timeFrame': 'Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part'}, {'measure': 'Relative Bioavailability (Frel) of GDC-0853', 'timeFrame': 'Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part'}, {'measure': 'Apparent Terminal Elimination Half-Life (t1/2) of GDC-0853', 'timeFrame': 'Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'From screening to the end of the study (approximately a maximum of 11 weeks)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the PK of GDC-0853 following changes to formulation and in the presence or absence of food, the proton pump inhibitor (rabeprazole), or both. This will be a 3-part open-label randomized study conducted in healthy adult participants. Approximately 63 subjects will be enrolled in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female (of non-childbearing potential) participants\n* Within body mass index range 18.0 to 32.0 kilogram per meter square (kg/m\\^2), inclusive\n* In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs and physical examinations\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm\n\nExclusion Criteria:\n\n* History or symptoms of any significant disease\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\n* Participants who previously participated in any other investigational study drug trial within 90 days prior to Check-in. Participants who previously received GDC-0853 in previous studies.\n* History of malignancy\n* Pregnancy, lactation, or breastfeeding in female participants'}, 'identificationModule': {'nctId': 'NCT03290703', 'briefTitle': 'A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase I, Single Center, Randomized, Open-Label Study Investigating the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics of GDC-0853 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'GP39619'}, 'secondaryIdInfos': [{'id': '2017-000752-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: GDC-0853 (Effect of Formulation)', 'description': 'Participants will receive five single oral doses of test formulations of GDC-0853 co-administered with rabeprazole in the fasted state.', 'interventionNames': ['Drug: GDC-0853', 'Drug: Rabeprazole']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: GDC-0853 (Effect of Food and Rabeprazole)', 'description': 'Participants will receive three single oral doses of one GDC-0853 formulations selected from Part 1 of this study. One dose will be administered in the fasted state, one dose will be administered in the fed state, and one dose will be co-administered with rabeprazole in the fed or fasted state, depending on randomization.', 'interventionNames': ['Drug: GDC-0853', 'Drug: Rabeprazole']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)', 'description': 'Participants will receive three single oral doses of an optimized tablet formulations of GDC-0853. One dose will be administered in the fasted state, one dose will be administered in the fed state, and one dose will be co-administered with rabeprazole in the fed or fasted state, depending on randomization.', 'interventionNames': ['Drug: GDC-0853', 'Drug: Rabeprazole']}], 'interventions': [{'name': 'GDC-0853', 'type': 'DRUG', 'otherNames': ['RO7010939'], 'description': 'Participants will receive different formulations of GDC-0853 tablet.', 'armGroupLabels': ['Part 1: GDC-0853 (Effect of Formulation)', 'Part 2: GDC-0853 (Effect of Food and Rabeprazole)', 'Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)']}, {'name': 'Rabeprazole', 'type': 'DRUG', 'description': 'Participants will receive rabeprazole 20 mg twice daily (BID) for three days prior to GDC-0853 administration and a single dose coadministered with GDC-0853.', 'armGroupLabels': ['Part 1: GDC-0853 (Effect of Formulation)', 'Part 2: GDC-0853 (Effect of Food and Rabeprazole)', 'Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Clinical Ltd, Clinical Research Unit', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}