A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.

Key facts

Study ID

NCT06812780

Run by

AstraZeneca

People needed

35

Starts

2025-02-04

Expected to finish

2025-09-04

Last updated by the study team

2025-09-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• For Hepatic:
• Participant with a diagnosis of stable hepatic impairment
• For Healthy:
• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
• All participants:
• Body weight ≥ 50 kg; BMI within the range of 18.0 to 42.0 kg/m2 (inclusive).

You may not qualify if…

• Participant has eGFR < 60 mL/minute/1.73 m2
• Positive test for HIV at screening
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity
• History of severe dermatological disorders

Where it is running

• Research Site — Chandler, Arizona, United States
• Research Site — Rialto, California, United States
• Research Site — Miami Lakes, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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