Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05879991
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2023-05-25
Brief Title:
A Study in Healthy Men to Test How BI 1810631 is Taken up and Processed by the Body
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Phase I Open-label Trial in Two Parallel Parts to Investigate Mass Balance Metabolism and Basic Pharmacokinetics of BI 1810631 C-14 Administered as Oral Solution Part A and to Investigate Absolute Bioavailability of BI 1810631 Administered as Film-coated Tablet Together With an Intravenous Microtracer Dose of BI 1810631 C-14 Part B in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2024-10
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:
Part A - the primary objective is to assess the mass balance and total recovery of 14C-radioactivity in urine and faeces after oral single dose administration of BI 1810631 C-14 test treatment T1 in healthy male subjects
Part A - the secondary objective is to assess concentrations of BI 1810631 and 14C-radioactivity in plasma
Part B - the primary objective is to investigate the absolute bioavailability of BI 1810631 administered as film-coated tablet test treatment T2 not radio-labelled compared with BI 1810631 C-14 reference treatment R administered as intravenous microtracer
Part A - the secondary objective is to assess concentrations of BI 1810631 and 14C-radioactivity in plasma
Part B - the primary objective is to investigate the absolute bioavailability of BI 1810631 administered as film-coated tablet test treatment T2 not radio-labelled compared with BI 1810631 C-14 reference treatment R administered as intravenous microtracer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-503047-17-00 | REGISTRY | None | None |
| U1111-1291-2883 | REGISTRY | WHO registry | None |