Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04567316
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2020-09-25
Brief Title:
A Study in Healthy Men to Test How BI 1358894 is Taken up and Handled by the Body
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Phase I Open-label Trial to Investigate Metabolism and Pharmacokinetics of a Single Dose of 14C BI 1358894 Administered as Oral Solution Part 1 and Multiple Doses of BI 1358894 Administered as Film-coated Tablets Part 2 in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2021-01
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 main objective of this trial is to investigate the basic pharmacokinetics of BI 1358894 and its metabolites total radioactivity including mass balance excretion pathways and metabolism following a single oral dose of 14C BI 1358894 in Part 1 and to investigate the pharmacokinetics of BI 1358894 and its metabolites following multiple-dose treatment over 21 days with non- radiolabelled compound of BI 1358894 in Part 2
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-002054-25 | EUDRACT_NUMBER | None | None |