Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520553
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
A Study in Healthy Men to Test How BI 1569912 is Processed in the Body
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Double-micro-tracer Human Absorption Distribution Metabolism and Excretion hADME and Absolute Bioavailability Trial After a Single Oral Dose of BI 1569912 C-14 and a Single Concomitant Intravenous Micro-dose of BI 1569912 C-13 in Healthy Male Subjects a Phase I Open-label Non-randomised Single-dose Fixed-sequence Trial
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objectives of this trial are
To investigate basic pharmacokinetics of BI 1569912 and total radioactivity including mass balance excretion pathways and metabolism following oral administration of BI 1569912 C-14 to healthy male subjects test treatment T
To investigate the absolute bioavailability of BI 1569912 as single oral solution dose using a single concomitant intravenous micro-tracer administration of BI 1569912 C-13 reference treatment R
To investigate basic pharmacokinetics of BI 1569912 and total radioactivity including mass balance excretion pathways and metabolism following oral administration of BI 1569912 C-14 to healthy male subjects test treatment T
To investigate the absolute bioavailability of BI 1569912 as single oral solution dose using a single concomitant intravenous micro-tracer administration of BI 1569912 C-13 reference treatment R
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None