Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT04789304
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2021-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Test How Healthy Men Tolerate Different Doses of BI 1595043
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1595043 (Double-blind, Randomised, Placebocontrolled, Parallel Group Design) in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2023-07
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:
The primary objectives of this trial are to investigate safety and tolerability of BI 1595043 in healthy male subjects following administration of multiple rising doses over 14 days.
Secondary objectives are the exploration of pharmacokinetics (PK) of BI 1595043 after single and multiple dosing.
Secondary objectives are the exploration of pharmacokinetics (PK) of BI 1595043 after single and multiple dosing.
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 |
|---|---|---|---|---|
| 2020-004923-18 | EUDRACT_NUMBER | None | View |