Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03420742
Status:
COMPLETED
Last Update Posted:
2023-01-27
First Post:
2018-01-29
Brief Title:
A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Participants With ALK-Positive or ROS1-Positive Solid Tumors
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors
Status:
COMPLETED
Status Verified Date:
2022-04
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 purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram mg once daily QD on the single-dose pharmacokinetics PK of midazolam
Detailed Description:
The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment This study will consist of 2 parts Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression PD All participants will receive study drug via the oral route Participants will be assigned to Midazolam 3 mg Brigatinib 90 mg
The overall time to participate in this study is 26 months Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B and a 30-day follow-up period after end of treatment
The overall time to participate in this study is 26 months Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B and a 30-day follow-up period after end of treatment
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-001624-19 | EUDRACT_NUMBER | WHO | None |
| U1111-1203-0166 | OTHER | None | None |