Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755088
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2021-02-04
Brief Title:
Surufatinib Renal Impairment Study
Sponsor:
Hutchison Medipharma Limited
Organization:
Hutchmed
Study Overview
Official Title:
A Phase 1 Study To Assess The Effect Of Moderate Renal Impairment On The Pharmacokinetics Of Surufatinib
Status:
COMPLETED
Status Verified Date:
2022-11
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 assess the effect of moderate renal impairment on the pharmacokinetics of surufatinib
Detailed Description:
An open-label multicenter single-dose single-period sequential study with the primary objective of assessing the effect of moderate renal impairment on the PK of surufatinib following administration of 300mg single oral dose The secondary objective is to evaluate the safety in subjects with moderate renal impairment and subjects with normal renal function following a single oral dose of 300mg surufatinib
Approximately 16 subjects will be enrolled
Approximately 16 subjects will be enrolled
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