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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04068532
• Other study ID #: 263HV101
• Secondary ID: 2019-001104-38
• Status: Completed
• Phase: Phase 1
• Start date: November 15, 2019
• Est. completion date: November 11, 2020

Study information

• Verified date: March 2021
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 11, 2020
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Placebo
Administered as specified in the treatment arm.
• BIIB104
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.	Screening up to Day 44
Secondary	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
Secondary	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
Secondary	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
Secondary	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