Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568861
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
A Study to Evaluate the Pharmacokinetics Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Non-Randomized Open-Label Multiple Dose Study to Evaluate the Pharmacokinetics Safety and Tolerability of ALG-097558 in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1 non-randomized open-label multiple dose parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic impairment matched for age body weight and to the extent possible for gender The primary purpose of this study is to characterize the effect of hepatic impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple twice daily Q12H oral PO doses
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None