Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-02-20 @ 11:32 AM
Study NCT ID:
NCT03871595
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2019-03-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study in Healthy Men to Test Whether Food Affects the Amount of BI 894416 in the Blood
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Relative Bioavailability of BI 894416 as Tablet Formulation Following a High-fat, High-calorie Breakfast Compared to Administration in the Fasting State in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)
Status:
COMPLETED
Status Verified Date:
2022-09
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:
Investigate the relative bioavailability of BI 894416 as tablet formulation following a high-fat, high calorie breakfast (Test, T) compared with administration in the fasting state (Reference, R)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-004313-41 | EUDRACT_NUMBER | None | View |