Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504862
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines Dabigatran Rosuvastatin Metformin and Furosemide in the Blood
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Zongertinib on the Pharmacokinetics of Dabigatran Part 1 and Rosuvastatin Metformin and Furosemide Administered as a Cocktail Part 2 in Healthy Male Subjects a 2-part Open-label 2-period Fixed-sequence Cross-over Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For Part 1 of the trial the main objective is to assess the effect of a single dose of zongertinib on the pharmacokinetics of a single dose of dabigatran-etexilate For Part 2 of the trial the main objective is to assess the effect of zongertinib at steady-state on the pharmacokinetics of a single dose of rosuvastatin metformin and furosemide administered as a cocktail
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None