Pharmacokinetics of mitiperstat in participants with hepatic impairment

Study identifier:D6581C00002

ClinicalTrials.gov identifier:NCT05751759

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

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

Medical condition

Hepatic Impairment

Phase

Phase 1

Healthy volunteers

No

Study drug

Mitiperstat

Sex

All

Estimated Enrollment

32

Study type

Interventional

Age

18 Years - 85 Years

Date

Study Start Date: 20 Mar 2023
Estimated Primary Completion Date: 20 Aug 2024
Estimated Study Completion Date: 20 Aug 2024

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria