Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

Study identifier:D7260C00011

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

Medical condition

Hepatic Impairment

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD5004

Sex

All

Estimated Enrollment

32

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 19 Dec 2024
Estimated Primary Completion Date: 22 Oct 2025
Estimated Study Completion Date: 22 Oct 2025

Study design

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

Verification:

Verified 01 Jan 2025 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Fortrea Clinical Research Unit Inc.

Inclusion and exclusion criteria