Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-26 @ 12:56 PM
Study NCT ID:
NCT05244759
Status:
COMPLETED
Last Update Posted:
2022-02-17
First Post:
2022-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-BLU-5937
Sponsor:
Bellus Health Inc. - a GSK company
Organization:
Study Overview
Official Title:
A Single Dose Study to Assess the Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-BLU-5937 in Healthy Male Subjects After Oral Dosing
Status:
COMPLETED
Status Verified Date:
2022-02
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:
None
Brief Summary:
This is a single-centre, open-label, non-randomised, single-period, single-dose study in healthy male subjects designed to assess the mass balance recovery, PK, metabolite profile and metabolite identification of \[14C\]-BLU-5937.
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?: