Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-02-25 @ 8:50 PM
Study NCT ID:
NCT05337592
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2022-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study in Healthy Men to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body With or Without Food
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 1815368 Administered as Oral Solution to Healthy Male Subjects (SRD Part), and a Randomised, Open-label, Single-dose, Three-way Cross-over Part Investigating Relative Bioavailability of BI 1815368 as Tablet Versus Oral Solution and Tablet With and Without Food in Healthy Male Subjects (BA Part)
Status:
COMPLETED
Status Verified Date:
2022-10
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:
Single-rising dose (SRD) part The main objectives of the SRD part of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1815368 in healthy male subjects following oral administration of single rising doses.
Bioavailability (BA) part The main objective of the BA part is to investigate the relative bioavailability of a tablet formulation versus oral solution and to assess the influence of food on the relative bioavailability of the tablet formulation.
Bioavailability (BA) part The main objective of the BA part is to investigate the relative bioavailability of a tablet formulation versus oral solution and to assess the influence of food on the relative bioavailability of the tablet formulation.
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 |
|---|---|---|---|---|
| 2021-006856-16 | EUDRACT_NUMBER | None | View |