Can a damaged liver change how a new drug works?
NCT ID NCT07783308
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This early-stage trial is investigating how a single oral dose of the experimental drug AZD4144 is processed by the body in people with mild, moderate, or severe liver impairment compared to healthy volunteers. The goal is to measure how liver function affects drug levels in the blood and to assess safety and tolerability. The study involves about 30 participants and is not designed to test the drug's effectiveness for any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AZD4144 (an experimental oral drug)
- What this could lead to
- If successful, this study could help determine the right dosing of AZD4144 for people with liver problems, potentially making future treatments safer and more effective for them.
- What could go wrong
- This is an early-phase study with a small number of participants. Results may not reflect real-world use, and the drug could still have unexpected side effects or fail in later trials.
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
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Aug 2026
An estimate. Start dates often move.
- Expected to finish
-
May 2027
An estimate. End dates often move.
- 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 80 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: Healthy Matched Control Participants Only (Group 4): • Must be medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or 12-lead ECGs, as deemed by the investigator at screening and Day -1. Hepatically-Impaired Participants Only (Groups 1, 2, and 3): * Must have a diagnosis of chronic (≥ 6 months) and stable hepatic impairment (e.g., no clinically significant change in signs, symptoms, or laboratory parameters of hepatic disease status within 30 days prior to study screening, as determined by the investigator at screening and Day -1). * Must be classified by the investigator as CP Class A (Group 1), CP Class B (Group 2), or CP Class C (Group 3) at screening. * Participant must be stable on a concomitant medication and/or treatment regimen (defined as not starting a new treatment/medication\[s\] or a change in the dosage or frequency of the concomitant medication\[s\] within at least 2 weeks prior to screening). All Groups: * Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 45 kg/m2, inclusive. * All Females of Childbearing Potential (FOCBP) must have a negative pregnancy test at screening and Day -1. Exclusion Criteria: * History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study. * Have Type 1 diabetes mellitus or T2DM (Group 4) * Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection. * History of long QT syndrome or prolonged QTcF. * Presence of unstable medical or psychological conditions, or any evidence of additional severe or uncontrolled systemic disease (e.g., currently unstable or uncompensated renal, cardiovascular, or respiratory disease). * Evidence of renal impairment at screening * Current liver transplant or anticipated to receive liver transplant within 2 months of screening or Day -1 (Group 1, 2 and 3). * Use of any of the prescription and non-prescription prohibited medications. * Concomitant immunosuppressive, steroid treatment. * Live or attenuated vaccines within 3 months prior to study intervention or live vaccinations planned during the trial. * History of severe allergy/hypersensitivity of AZD4144 or any of the excipients of the product. * Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days prior to study intervention in this study or, if known, 5 half-lives from last dose in the previous study to study intervention in this study, whichever is longest.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hepatic impairment are added.
By submitting, you agree to our Terms of use
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
4 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Research Site
Mesa, Arizona, 85210, United States
-
Research Site
Miami Lakes, Florida, 33014, United States
-
Research Site
Orlando, Florida, 32809, United States
-
Research Site
Austin, Texas, 78757, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A phase 1 Open-Label, Single-Dose, Parallel-Group study of the pharmacokinetics and safety of VIR-2218 and VIR-3434 monotherapy and combination therapy in adult participants with hepatic impairment
- Liver health and drug processing: a closer look at casdatifan
- Liver function may change how belapectin works in the body
- Liver function may change how ammoxetine works
- Liver function may affect how Weight-Loss drug petrelintide works
- Liver health may change how a promising cancer drug works in the body