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Completed

NCT Number: NCT04068532

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

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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Key information

Conditions

Healthy Volunteers

Age range

21 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, NW10 7EW, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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/exclusion criteria may apply.

Treatment and study plan

Placebo

Drug

Administered as specified in the treatment arm.

BIIB104

Drug

Administered as specified in the treatment arm.

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

    Time frame: Baseline, Day 4

Secondary outcomes

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

    Time frame: 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.

  2. 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

    Time frame: Baseline, Day 1, Day 4

  3. 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

    Time frame: Baseline, Day 1, Day 4

  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

    Time frame: Baseline, Day 1, Day 4

  5. 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

    Time frame: Baseline, Day 1, Day 4

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2019
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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