NCT05751759

Pharmacokinetics of Mitiperstat in Participants With Hepatic Impairment

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Mitiperstat	Participants receive mitiperstat orally.

Timeline

• Start date: 2023-03-20
• Primary completion: 2024-11-21
• Completion: 2024-11-21
• First posted: 2023-03-02
• Last updated: 2024-12-05

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study