Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT05751759
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.
Study:
NCT05751759
Study Brief:
Protocol Section:
NCT05751759