NCT04068532

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Biogen · Industry
• Sex: Male
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Placebo	Administered as specified in the treatment arm.
DRUG	BIIB104	Administered as specified in the treatment arm.

Timeline

• Start date: 2019-11-15
• Primary completion: 2020-11-11
• Completion: 2020-11-11
• First posted: 2019-08-28
• Last updated: 2021-03-22

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study