Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-20 @ 8:30 PM
Study NCT ID:
NCT02471859
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2015-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-15', 'studyFirstSubmitDate': '2015-06-11', 'studyFirstSubmitQcDate': '2015-06-11', 'lastUpdatePostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants experiencing an adverse event', 'timeFrame': 'Up to approximately 6 months'}], 'secondaryOutcomes': [{'measure': 'Maximum concentration (Cmax) for GDC-3280', 'timeFrame': 'Up to 4 days'}, {'measure': 'Time to Cmax (Tmax) for GDC-3280', 'timeFrame': 'Up to 4 days'}, {'measure': 'Total serum clearance for GDC-3280', 'timeFrame': 'Up to 4 days'}, {'measure': 'Volume of distribution for GDC-3280', 'timeFrame': 'Up to 4 days'}, {'measure': 'Elimination half-life for GDC-3280', 'timeFrame': 'Up to 4 days'}, {'measure': 'Serum GDC-3280 concentration-time data by dosing group', 'timeFrame': 'Up to 4 days'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Is male or female, using highly effective contraception\n* Has a body mass index (BMI) 18.0 to 30.0 kg/m2, inclusive\n* Is in good general health\n* Having signed informed consent, is willing and able to comply with requirements of the study\n\nExclusion Criteria:\n\n* Does not satisfy all screening criteria per protocol\n* Is employed by or related to any personnel involved in the trial\n* Has any history or condition that per protocol or in the opinion of the investigator could compromise the participant's safety or analysis of results"}, 'identificationModule': {'nctId': 'NCT02471859', 'briefTitle': 'A Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral-Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'GB29751'}, 'secondaryIdInfos': [{'id': '2015-000560-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: GDC-3280', 'description': 'Participants in multiple cohorts and treatment periods will receive single doses of GDC-3280 under fed/fasting conditions.', 'interventionNames': ['Drug: GDC-3280']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Placebo', 'description': 'Participants in multiple cohorts and treatment periods will receive single doses of placebo under fed/fasting conditions.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: GCD-3280', 'description': 'Participants in different cohorts will receive GDC-3280 in multiple ascending doses under fed/fasting conditions.\\\\n', 'interventionNames': ['Drug: GDC-3280']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Placebo', 'description': 'Participants in different cohorts will receive placebo in multiple ascending doses under fed/fasting conditions.\\\\n', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GDC-3280', 'type': 'DRUG', 'description': 'GDC-3280 at various doses, depending on the cohort and treatment period', 'armGroupLabels': ['Part A: GDC-3280', 'Part B: GCD-3280']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo at various doses, depending on the cohort and treatment period', 'armGroupLabels': ['Part A: Placebo', 'Part B: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 9LH', 'city': 'Leeds', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}