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

NCT04068532 | Completed Phase 1 FDA Drug

• 2 other identifiers: 263HV1012019-001104-38
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Screening up to Day 44

• 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

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

BIIB104

EXPERIMENTAL

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

Drug: BIIB104

Interventions

Placebo DRUG

Administered as specified in the treatment arm.

Placebo

BIIB104 DRUG

Administered as specified in the treatment arm.

BIIB104

Eligibility Criteria

• Age: 21 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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) \[Oldfield 1971\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

London, NW10 7EW, United Kingdom

Location

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: November 15, 2019
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)