Ignite Creation Date:
2024-07-17 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494761
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-03
Brief Title:
A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines Midazolam Omeprazole and Repaglinide Are Taken up and Processed by the Body
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
The Effect of Multiple Doses of Zongertinib on the Single-dose Pharmacokinetics of Midazolam Omeprazole and Repaglinide in Healthy Male Subjects an Open-label 2-period Fixed-sequence 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:
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 assess the effect of multiple oral doses of zongertinib on the pharmacokinetics of midazolam omeprazole and repaglinide
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-510263-35-00 | REGISTRY | None | None |
| U1111-1301-9035 | REGISTRY | None | None |