Can a damaged liver change how a new drug works?

NCT ID NCT07783308

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

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