Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-02 @ 5:28 AM
Study NCT ID:
NCT05751759
Status:
COMPLETED
Last Update Posted:
2024-12-05
First Post:
2023-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Mitiperstat in Participants With Hepatic Impairment
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Phase I Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Mitiperstat
Status:
COMPLETED
Status Verified Date:
2024-12
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 study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of mitiperstat.
Detailed Description:
This is a Phase I, single dose, non-randomised, open-label, parallel group study to examine the PK, safety, and tolerability of mitiperstat in participants with hepatic impairment and participants with normal hepatic function.
Participants will be assigned to one of the following cohorts as per Child-Pugh classification:
* Cohort 1: Eight participants with Mild hepatic impairment (Child-Pugh A)
* Cohort 2: Eight participants with Moderate hepatic impairment (Child-Pugh B)
* Cohort 3: Six to eight participants with Severe hepatic impairment (Child-Pugh C)
* Cohort 4: Eight to twelve participants with Normal hepatic function
A final safety follow-up visit on Day 21 will be there after all procedures are completed on Day 15.
Participants will be assigned to one of the following cohorts as per Child-Pugh classification:
* Cohort 1: Eight participants with Mild hepatic impairment (Child-Pugh A)
* Cohort 2: Eight participants with Moderate hepatic impairment (Child-Pugh B)
* Cohort 3: Six to eight participants with Severe hepatic impairment (Child-Pugh C)
* Cohort 4: Eight to twelve participants with Normal hepatic function
A final safety follow-up visit on Day 21 will be there after all procedures are completed on Day 15.
Study Oversight
Has Oversight DMC:
False
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?: