Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
Study NCT ID:
NCT04305392
Status:
UNKNOWN
Last Update Posted:
2022-08-10
First Post:
2020-03-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment
Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Organization:
Study Overview
Official Title:
Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment (Multicenter, Single Dose, Parallel, Open)
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
ACTIVE_NOT_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:
Study to evaluate pharmacokinetics, pharmacodynamics and safety of SHR4640 in patients with mild, moderate hepatic impairment and normal liver function in phase I clinical study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: