Ignite Creation Date:
2024-05-06 @ 10:24 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03245307
Status:
UNKNOWN
Last Update Posted:
2018-02-07
First Post:
2017-07-17
Brief Title:
A Study To Test The Effect Of Apatinib On P450 Enzymes
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A Single-center Open-Label Drug Interaction Study to Determine the Effects of Apatinib on the Metabolism of CYP3A45 and CYP2C9 Probe Drugs in Patients With Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
RECRUITING
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:
Apatinib an oral inhibitor of vascular endothelial growth factor receptor 2VEGFR-2 inhibits multiple cytochrome P450 CYP450 enzymes in vitro This study in patients with advanced cancer evaluated the effect of Apatinib on CYP450 function by comparing the pharmacokinetics of CYP-specific probe drugs in the presence and absence of Apatinib The probes used included Nifedipine CYP3A specific warfarin CYP2C9 specific
Detailed Description:
This open-label study consists of a drug interaction phase that part A and a drug-continuation phase part B Patients will receive CYP450-probe drugs and PK assessments will be performed before apatinib-administration and aſter once-daily administration of apatinib for 5 days the predicted time point when steady-state plasma apatinib concentrations will have been achieved
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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