Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-29 @ 5:33 AM
Study NCT ID:
NCT06084104
Status:
COMPLETED
Last Update Posted:
2024-12-18
First Post:
2023-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DZD9008 PK Study in Hepatic Impairment Subjects
Sponsor:
Dizal Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 1, Single-Dose, Non-Randomized, Open Label Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of DZD9008
Status:
COMPLETED
Status Verified Date:
2024-12
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 study will investigate the pharmacokinetics, safety, and tolerability of DZD9008 in subjects with hepatic impairment compared to subjects with normal hepatic function
Detailed Description:
None
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?: