Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755075
Status:
COMPLETED
Last Update Posted:
2022-08-30
First Post:
2021-02-04
Brief Title:
Surufatinib Hepatic Impairment Study
Sponsor:
Hutchison Medipharma Limited
Organization:
Hutchmed
Study Overview
Official Title:
A Phase 1 Study To Assess The Effect Of Hepatic Impairment On The Pharmacokinetics Of Surufatinib
Status:
COMPLETED
Status Verified Date:
2022-08
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:
An open-label multicenter single-dose single-period sequential study to determine the effect of hepatic impairment on the PK of surufatinib
Detailed Description:
This is a phase 1 open-label multicenter single-dose single-period sequential study with the primary objective of determining the effect of moderate and mild hepatic impairment on the PK of surufatinib The secondary objective is to evaluate the safety in subjects with moderate and mild if enrolled hepatic impairment and subjects 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