NCT06311786

A Study to Look at How a Single Oral Dose of Carbon-14-Labelled [14C] BIIB091 Moves Through and is Processed by the Body in Healthy Male Participants

A Phase 1, Open-Label Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of Single Oral Dose [14C]-BIIB091 in Healthy Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Biogen · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main goal of this study is to learn how \[14C\]-BIIB091 moves through and is processed by the body and to look at how much of BIIB091's metabolites (what is produced when BIIB091 is broken down by the body) appears in the blood, urine, and stool in healthy male participants. The study will also help researchers learn more about the safety of BIIB091 in healthy male participants.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	[14C]-BIIB091	Administered as specified in the treatment arm.

Timeline

• Start date: 2024-04-08
• Primary completion: 2024-05-11
• Completion: 2024-05-11
• First posted: 2024-03-15
• Last updated: 2024-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study