Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311786
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2024-03-08
Brief Title:
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
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mass Balance
Brief 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 BIIB091s 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None