Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT06655220
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2024-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study in Healthy Men to Test Whether BI 1815368 Influences the Amount of Metformin in the Body
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Investigation of the Effect of BI 1815368 on the Pharmacokinetics of Metformin Following Multiple Oral Administration in Healthy Subjects (an Open-label, Randomised, Two-way Crossover Trial)
Status:
COMPLETED
Status Verified Date:
2025-03
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:
The main objective of this trial is to investigate the effect on the exposure of metformin in plasma when administered as an oral multiple dose together with multiple oral doses of BI 1815368 (Test, T) as compared to when metformin is administered as an oral multiple dose alone (Reference, R).
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?: