Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572111
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
A Study in Healthy Men to Test How BI 1839100 is Taken up and Handled by the Body
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Open-label Trial to Investigate the Metabolism Pharmacokinetics Following a Mass Balance Design Part A and Absolute Bioavailability of BI 1839100 C-14 After Oral and Intravenous Administration Part B in Healthy Male Subjects
Status:
RECRUITING
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:
This trial is conducted in healthy male subjects to evaluate the drug BI 1839100 The trial has two main parts Part A aims to understand how BI 1839100 is processed in the body after an oral dose It measures the total recovery of the drug and its radioactive label in urine and feces It also determines the concentrations in blood plasma and investigates the drugs metabolic pathways Part B aims to compare the absolute bioavailability of BI 1839100 when administered orally and intravenously
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