Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT03596632
Status:
COMPLETED
Last Update Posted:
2018-12-06
First Post:
2018-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619415', 'term': 'fenebrutinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-05', 'studyFirstSubmitDate': '2018-07-13', 'studyFirstSubmitQcDate': '2018-07-13', 'lastUpdatePostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Percentage of the Total Radioactive Dose Administered Excreted from Urine and Feces"; TimeFrame: "Day 1 to end of study (approximately 35 days post-dose)', 'timeFrame': 'Screening to end of study (approximately 35 days post-dose)', 'description': "An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any AE that can be fatal, life threatening, prolongs inpatient hospitalization, significant disability, congenital anamoly, is a significant medical event in the Investigator's judgment."}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax) of Fenebrutinib and its Metabolites', 'timeFrame': 'Day 1 pre-dose to end of study (approximately 35 days post-dose)'}, {'measure': 'Time to Observed Maximum Concentration (Tmax) of Fenebrutinib and its Metabolites', 'timeFrame': 'Day 1 pre-dose to end of study (approximately 35 days post-dose)'}, {'measure': 'Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) of Fenebrutinib and its Metabolites', 'timeFrame': 'Day 1 pre-dose to end of study (approximately 35 days post-dose)'}, {'measure': 'Area under the Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) of Fenebrutinib and its Metabolites', 'timeFrame': 'Day 1 pre-dose to end of study (approximately 35 days post-dose)'}, {'measure': 'Cumulative Percent of Total Radioactivity Excreted in Urine Over the Sampling Interval (Total % Feu)', 'timeFrame': 'Day 1 pre-dose to end of study (approximately 35 days post-dose)'}, {'measure': 'Cumulative Percent of Total Radioactivity Excreted in Feces Over the Sampling Interval (Total % Fef)', 'timeFrame': 'Day 1 pre-dose to end of study (approximately 35 days post-dose)'}, {'measure': 'Number of Participants With Clinical Significant Changes in Vital Signs', 'timeFrame': 'Screening up to Day 31', 'description': 'Vital signs incudes oral temperature, respiratory rate, supine blood pressure and pulse.'}, {'measure': 'Number of Participants With Clinical Significant Changes in Physical Examination Findings', 'timeFrame': 'Day -1, 28', 'description': 'Physical examination will consist of an assessment of general appearance, skin, thorax/lungs, abdomen, lymph nodes, head, ears, eyes, nose, throat, neck (including thyroid); and cardiovascular, musculoskeletal, and neurological systems.'}, {'measure': 'Number of Participants With Clinical Significant Changes in Clinical Laboratory Results', 'timeFrame': 'Screnning, Day -1, 2, 4, 28', 'description': 'Laboratory analysis include chemistry panel, complete blood count and urinalysis.'}, {'measure': 'Number of Participants With Clinical Significant Changes in Electrocardiograms (ECGs)', 'timeFrame': 'Screening, Day-1, 1 (Pre-dose; 1, 3 hours [h] post-dose), 28, 31'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the excretion kinetics and mass balance of fenebrutinib in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects, between 18 and 60 years of age, inclusive\n* Within body mass index range 18 to 32 kg/m2, inclusive\n* In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs, and physical examination\n* For males who are sterile: agreement to use a condom with a fertile or pregnant female partner from Day -1 until 90 days following Study Completion; for males who are fertile: agreement to use a condom with spermicide with a fertile or pregnant female partner from Day -1 until 90 days following Study Completion\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, unless approved by the Investigator\n* History of stomach or intestinal surgery or resection, except appendectomy, hernia repair, and cholecystectomy\n* History of malignancy, except for non-melanoma skin carcinoma with 3-year disease-free follow-up\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 Day -1\n* Exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Day -1\n* Participation in a radiolabeled drug study in which exposures are known to the Investigator within 4 months prior to Day -1, or participation in a radiolabeled drug study in which exposures are not known to the Investigator within 6 months prior to Day -1. The total 12-month exposure from this study and a maximum of 2 other studies must be within the Code of Federal Regulations (CFR) recommended levels considered state (per 21 CFR 361.1), e.g. less than 5,000 mrem whole body annual exposure'}, 'identificationModule': {'nctId': 'NCT03596632', 'briefTitle': 'Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase 1 Open-label Study Investigating the Excretion Balance, Pharmacokinetics, and Metabolism of a Single Oral Dose of [14C/12C]-Labeled Fenebrutinib in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'GP40605'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Oral Solution Dose', 'description': 'Single 200-mg (approximately 100-µCi) oral solution dose of \\[14C/12C\\]-fenebrutinib under fasted conditions.', 'interventionNames': ['Drug: Fenebrutinib']}], 'interventions': [{'name': 'Fenebrutinib', 'type': 'DRUG', 'otherNames': ['RO7010939'], 'description': '200-mg (100 µCi) oral solution 14C/12C\\]-fenebrutinib', 'armGroupLabels': ['Single Oral Solution Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Covance Clinical Research Unit, Inc', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}