Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-07 @ 6:08 AM
Study NCT ID:
NCT04068532
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2019-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Explore Pharmacodynamic Effects of BIIB104 on Brain Circuitry 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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-19', 'studyFirstSubmitDate': '2019-08-22', 'studyFirstSubmitQcDate': '2019-08-22', 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Faces Versus Shapes Emotional Faces Task Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Contrasts to Day 4 Within a Priori Defined Regions of Interest', 'timeFrame': 'Baseline, Day 4'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Screening up to Day 44', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death, in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event), however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.'}, {'measure': 'Change From Baseline in Emotional Faces Task Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Contrasts to Day 1 and Day 4 Within a Priori Defined Regions of Interest', 'timeFrame': 'Baseline, Day 1, Day 4'}, {'measure': 'Change From Baseline in N-Back Task Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Contrasts to Day 1 and Day 4 Within a Priori Defined Regions of Interest', 'timeFrame': 'Baseline, Day 1, Day 4'}, {'measure': 'Change From Baseline in Arterial Spin Labeling (ASL)-Derived Maps of Regional Cerebral Blood Flow (CBF) at Rest to Day 1 and Day 4 Within a Priori Defined Regions of Interest', 'timeFrame': 'Baseline, Day 1, Day 4'}, {'measure': 'Change From Baseline in Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI)-Derived Intrinsic Functional Connectivity Networks at Rest to Day 1 and Day 4 Within a Priori Defined Regions of Interest', 'timeFrame': 'Baseline, Day 1, Day 4'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to explore the pharmacodynamic (PD) effects of BIIB104 on brain circuitry associated with emotional processing in healthy participants.\n\nThe secondary objectives of the study are to evaluate the safety and tolerability of BIIB104 in healthy participants; To further explore the PD effects of BIIB104 on brain circuitry associated with emotional processing in healthy participants; To explore the PD effects of BIIB104 on brain circuitry associated with working memory in healthy participants using the N-Back; To explore the PD effects of BIIB104 on regional cerebral blood flow (CBF) in healthy participants; To explore the PD effects of BIIB104 on brain circuitry during resting state in healthy participants.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\\^2), inclusive.\n* Right-handed as determined by the Edinburgh Handedness Inventory (score of \\>40) \\[Oldfield 1971\\].\n\nKey Exclusion Criteria:\n\n* Previous participation in this study or previous studies with BIIB104.\n* Body weight \\<55 kg.\n* History of severe allergic or anaphylactic reactions, or systemic hypersensitivity reaction to BIIB104 or any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment.\n\nNOTE: Other protocol defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04068532', 'briefTitle': 'A Study to Explore Pharmacodynamic Effects of BIIB104 on Brain Circuitry in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 2-Period, 2-Sequence Crossover Study to Explore Pharmacodynamic Effects of BIIB104 on Brain Circuitry Using BOLD Functional MRI and Arterial Spin Labeling in Healthy Participants', 'orgStudyIdInfo': {'id': '263HV101'}, 'secondaryIdInfos': [{'id': '2019-001104-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive matching placebo to BIIB104 on Days 1-4 in treatment periods 1 or 2.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BIIB104', 'description': 'Participants will receive BIIB104 on Days 1-4 in treatment periods 1 or 2.', 'interventionNames': ['Drug: BIIB104']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered as specified in the treatment arm.', 'armGroupLabels': ['Placebo']}, {'name': 'BIIB104', 'type': 'DRUG', 'description': 'Administered as specified in the treatment arm.', 'armGroupLabels': ['BIIB104']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW10 7EW', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'ipdSharing': 'YES', 'description': "In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}