Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04473664
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2020-07-13
Brief Title:
A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
An Open-label Single-dose Study to Assess the Pharmacokinetics Safety and Tolerability of Quizartinib in Subjects With Moderate Impaired Hepatic Function as Defined by NCI-ODWG Criteria
Status:
COMPLETED
Status Verified Date:
2022-09
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:
Quizartinib is a novel oral Class III receptor tyrosine kinase RTK inhibitor exhibiting highly potent and selective but reversible inhibition of Feline McDonough sarcoma FMS-like tyrosine kinase 3 FLT3 Quizartinib is currently being studied alone or in combination with other agents as a treatment for acute myeloid leukemia AML and myelodysplastic syndrome MDS in adult and pediatric populations
Detailed Description:
The primary objective of this study is to determine the plasma pharmacokinetics PK of quizartinib and its pharmacologically active metabolite AC886 after a single oral dose of 30 mg in participants with moderate hepatic impairment HI as defined by National Cancer Institute-Organ Dysfunction Working Group NCI-ODWG criteria compared to the healthy control participants with normal hepatic function
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