A Study to Explore Pharmacodynamic Effects of BIIB104 on Brain Circuitry in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2020-11-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Participants will receive matching placebo to BIIB104 on Days 1-4 in treatment periods 1 or 2.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm.

BIIB104

Participants will receive BIIB104 on Days 1-4 in treatment periods 1 or 2.

Group Type EXPERIMENTAL

BIIB104

Intervention Type DRUG

Administered as specified in the treatment arm.

Interventions

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Placebo

Administered as specified in the treatment arm.

Intervention Type DRUG

BIIB104

Administered as specified in the treatment arm.

Intervention Type DRUG

Eligibility Criteria

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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) \[Oldfield 1971\].

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes