Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-25 @ 4:24 PM
Study NCT ID:
NCT05652257
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2022-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Absorption, Metabolism, and Excretion of [14C]-Brensocatib Following a Single Oral Administration in Healthy Male Participants
Sponsor:
Insmed Incorporated
Organization:
Study Overview
Official Title:
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Brensocatib Following a Single Oral Administration in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2023-03
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:
The primary purpose of the study is to determine the mass balance of total radioactivity and the routes of elimination by quantifying the urinary and fecal excretion of radioactivity following a single oral administration of \[14C\]-brensocatib, to characterize the pharmacokinetics (PK) of brensocatib in plasma and urine, PK of total radioactivity in plasma, whole blood, urine and to determine the blood-to-plasma ratios of total radioactivity.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: