NCT06813781

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with mild, moderate, and severe hepatic impairment compared with participants with normal hepatic function.

Detailed description

This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with mild, moderate, or severe hepatic impairment compared with participants with normal hepatic function. Participants will be enrolled within the following groups based on their Child Pugh classification score as determined at screening: Group 1: Participants with mild hepatic impairment (Child Pugh Class A, score of 5 or 6). Group 2: Participants with moderate hepatic impairment (Child Pugh Class B, score of 7 to 9). Group 3: Participants with severe hepatic impairment (Child Pugh Class C, score of 10 to 15). Group 4: Participants with normal hepatic function matched on a group level regarding sex, age, and body weight to the impaired participants.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	AZD5004	Dose 1

Timeline

• Start date: 2024-12-19
• Primary completion: 2025-10-02
• Completion: 2025-10-02
• First posted: 2025-02-07
• Last updated: 2025-10-15

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study