Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT04241458
Status:
COMPLETED
Last Update Posted:
2025-08-24
First Post:
2020-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Test How Well Healthy Men and Women Tolerate Different Doses of BI 706321
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 706321 in Healthy Male and Female Subjects (Doubleblind, Randomised, Placebo-controlled, Parallel Group Design)
Status:
COMPLETED
Status Verified Date:
2025-08
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 main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 706321 in healthy male and female subjects following oral administration of multiple rising doses for 14 days.
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 |
|---|---|---|---|---|
| 2019-004351-36 | EUDRACT_NUMBER | None | View |