Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06255340
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2024-02-05
Brief Title:
A Study in Healthy Men to Test How Different Doses of BI 3031185 Are Tolerated and How Food Influences the Amount of BI 3031185 in the Blood
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomised Single-blind Placebo-controlled Trial to Investigate Safety Tolerability and Pharmacokinetics of Single Rising Doses of BI 3031185 Administered as Tablet to Healthy Male Subjects and a Randomised Open-label Single-dose Two-way Cross-over Relative Bioavailability Comparison of BI 3031185 as Tablet With and Without Food in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2024-09
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:
This trial starts the clinical development of BI 3031185 The single rising dose SRD part of the trial investigates safety tolerability and pharmacokinetics of a range of single doses of BI 3031185 as basis for further development
The food effect FE part is conducted to assess the effect of food on the relative bioavailability of the BI 3031185 tablet formulation
The food effect FE part is conducted to assess the effect of food on the relative bioavailability of the BI 3031185 tablet formulation
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?:
None