Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-03 @ 10:04 AM
Study NCT ID:
NCT05520827
Status:
COMPLETED
Last Update Posted:
2023-03-09
First Post:
2022-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study in Healthy Men to Test How Different Doses of BI 1584862 Are Tolerated and How BI 1584862 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 1584862 Administered as Tablet to Healthy Male Subjects (SRD Part), and a Randomised, Open-label, Single-dose, Two-way Crossover Part Investigating Relative Bioavailability of BI 1584862 as Tablet With and Without Food in Healthy Male Subjects (FE Part)
Status:
COMPLETED
Status Verified Date:
2023-03
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 1584862 in healthy male subjects following oral administration of single rising doses.
Food Effect (FE) part:
The main objective of the FE part is to assess the influence of food on the relative bioavailability of the BI 1584862 tablet.
The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 1584862 in healthy male subjects following oral administration of single rising doses.
Food Effect (FE) part:
The main objective of the FE part is to assess the influence of food on the relative bioavailability of the BI 1584862 tablet.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-001019-15 | EUDRACT_NUMBER | None | View |