New drug tested in patients with liver disease – safety first
NCT ID NCT06812780
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study looked at how the drug AZD2389 behaves in people with liver impairment compared to healthy volunteers. 35 adults took a single dose, and researchers measured drug levels in the blood to check safety and processing. The goal is to understand if liver problems change how the drug works, which helps guide future dosing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AZD2389
- What this could lead to
- If successful, this study could help doctors determine the right dose of AZD2389 for patients with liver disease, making the drug safer to use.
- What could go wrong
- This is an early-stage study with only 35 participants. It focuses on how the body handles the drug, not on treating a disease, so it may not lead to a new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
35 people
The number who actually took part.
- Started
-
Feb 2025
- Finished
-
Sep 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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). Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Research Site
Chandler, Arizona, 85225, United States
-
Research Site
Rialto, California, 92377, United States
-
Research Site
Miami Lakes, Florida, 33014, United States
-
Research Site
Orlando, Florida, 32809, United States
-
Research Site
San Antonio, Texas, 78215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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