Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-05 @ 6:06 PM
Study NCT ID:
NCT04993404
Status:
COMPLETED
Last Update Posted:
2024-01-11
First Post:
2021-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics Of Jaktinib In Subjects With Hepatic Impairment And Normal Hepatic Function
Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Organization:
Study Overview
Official Title:
Study To Evaluate The Pharmacokinetics Of Jaktinib Hydrochloride Tablets In Subjects With Hepatic Impairment And Normal Hepatic Function
Status:
COMPLETED
Status Verified Date:
2024-01
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:
This multi-center, open-label, parallel-controlled, single-dose Phase 1 study is being conducted to directly characterize the pharmacokinetic (PK) profiles and safety of Jaktinib following administration of a single oral dose in subjects with varying degrees of hepatic impairment compared to healthy matched control subjects with normal hepatic function(matched by age, weight, and sex).
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?: