Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04796831
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2021-03-05
Brief Title:
A Study to Determine the Absolute Oral Bioavailability of Quizartinib Using a Radiolabeled Microtracer in Healthy Subjects
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
An Open Label Study to Determine the Absolute Oral Bioavailability of Quizartinib Using a Radiolabeled Microtracer in Healthy Subjects
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:
Quizartinib a selective FLT3 inhibitor is being developed as a treatment for acute myeloid leukemia AML and myelodysplastic syndrome MDS The absolute oral bioavailability of quizartinib has not yet been studied This study is designed to estimate quizartinib bioavailability of quizartinib following oral and intravenous IV administration
Detailed Description:
Quizartinib bioavailability based on the dose-adjusted exposure of quizartinib following oral and IV administration will be assessed in healthy male subjects The primary objective of this study is to determine the absolute oral bioavailability of quizartinib Secondary objectives will include characterizing the plasma PK of quizartinib radiolabeled quizartinib and the major circulating metabolite after a single oral dose and IV administration Safety and tolerability of quizartinib will also be assessed
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 |
|---|---|---|---|
| 2021-000198-10 | EUDRACT_NUMBER | None | None |