Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-27 @ 9:36 AM
Study NCT ID:
NCT02722161
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2016-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olmutinib (BI 1482694) ADME Study
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
A Phase I, Open-label, Single-dose Trial to Investigate Metabolism and Pharmacokinetics of [14C]BI 1482694 Administered as Oral Solution in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2016-07
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:
To investigate the basic pharmacokinetics of BI 1482694, its metabolites M1 and M2, and \[14C\]-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of \[14C\]BI 1482694 given to healthy male volunteers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-000190-20 | EUDRACT_NUMBER | EudraCT | View |