NCT06576765

Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD0780

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 AZD0780

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of AZD0780 with moderate and possibly mild hepatic impairment in comparison to a matched healthy control group.

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 AZD0780 dose 1 administered orally to male and female participants (females of non-childbearing potential) with moderate hepatic impairment and mild hepatic impairment (optional) compared with male and female participants (females of non-childbearing potential) 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 moderate hepatic impairment (Child Pugh Class B, score of 7 to 9). * Group 2: Participants with normal hepatic function demographically matched by sex, age, and body mass index (BMI) to the impaired participants. * Group 3 (optional): Participants with mild hepatic impairment (Child Pugh Class A, score of 5 or 6).

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	AZD0780	Dose 1

Timeline

• Start date: 2024-08-08
• Primary completion: 2024-11-08
• Completion: 2024-11-08
• First posted: 2024-08-29
• Last updated: 2025-02-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study