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

• Sponsor: Biogen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04068532
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.9
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Placebo; Drug: BIIB104	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 15, 2019
• Actual Primary Completion Date: Nov 11, 2020
• Actual Study Completion Date: Nov 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants will receive matching placebo to BIIB104 on Days 1-4 in treatment periods 1 or 2.	Drug: Placebo; Administered as specified in the treatment arm.
Experimental: BIIB104 Participants will receive BIIB104 on Days 1-4 in treatment periods 1 or 2.	Drug: BIIB104; Administered as specified in the treatment arm.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. 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.

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 [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 [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 [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 [Baseline, Day 1, Day 4]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	London		United Kingdom	NW10 7EW

Sponsors and Collaborators

• Biogen

Investigators

• Study Director: Medical Director, Biogen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT04068532
• Other Study ID Numbers: 263HV101; 2019-001104-38
• First Posted: Aug 28, 2019
• Last Update Posted: Mar 22, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 22, 2021