Healthy Volunteers
Conditions
Brief summary
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. The 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.
Interventions
DRUGPlacebo
Administered as specified in the treatment arm.
DRUGBIIB104
Administered as specified in the treatment arm.
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2), inclusive. * Right-handed as determined by the Edinburgh Handedness Inventory (score of \>40) \[Oldfield 1971\]. Key
Exclusion criteria
* Previous participation in this study or previous studies with BIIB104. * Body weight \<55 kg. * 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. NOTE: Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Baseline, Day 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Day 1, Day 4 | — |
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Screening up to Day 44 | 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. |
| 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 | Baseline, Day 1, Day 4 | — |
| 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 | Baseline, Day 1, Day 4 | — |
| 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 | Baseline, Day 1, Day 4 | — |
Countries
United Kingdom
Outcome results
None listed