Hepatic Impairment Clinical Trial
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
This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of mitiperstat.
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. ;
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