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Liver impairment study tests drug processing in 33 volunteers

NCT ID NCT06813781

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 study looked at how a single dose of the drug AZD5004 moves through the body in people with mild, moderate, or severe liver impairment compared to healthy volunteers. The goal was to measure drug levels and check safety. 33 adults aged 18-80 took part. The results will help guide future dosing for patients with liver issues.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD5004 (also known as ECC5004)
What this could lead to
If successful, this study could help doctors understand how to safely dose AZD5004 in patients with liver problems.
What could go wrong
This is a very early Phase 1 study with only 33 participants. It is designed to measure drug levels, not to treat any disease, so it may not lead to a 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

33 people

The number who actually took part.

Started

Dec 2024

Finished

Oct 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 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: For ALL participants: * Adults 18-80 years of age * Weight ≥50kg and BMI between ≥18 to ≤40 kg/m2 For participants with normal hepatic function: * Participant must be stable on a concomitant medication and/or treatment regimen for at least 2 weeks prior to screening For Healthy Controls: -Participant must be medically healthy with no significant findings on medical evaluation at screening to include but not limited to an eGFR \>90 ml/min/1.73 m2 For participants with hepatic impairment: * Group 1 (mild) must have an Child-Pugh score of 5 or 6, Group 2 (moderate) must have a Child-Pugh score of 7 to 9, Group 3 (severe) must have a Child-Pugh score of 10 to 15. * Participant must have a diagnosis of chronic (≥ 6 months) and stable hepatic impairment (eg, no clinically significant change in signs, symptoms, or laboratory parameters of hepatic disease status within 30 days prior to study screening Exclusion Criteria: For ALL participants: * Poorly controlled diabetes mellitus (A1C \>10% at screening). * Unwillingness to use adequate contraception * Uncontrolled hypertension or hypotension * Presence of unstable systemic disease or psychologic conditions. * Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG. Specific For Healthy Controls: -Positive screening for HIV, Hepatitis B, or Hepatitis C - -Any clinically significant disease or disorder to include but not limited to acute or chronic liver disease Specific For Hepatically Impaired Participants: * eGFR \<60 ml/min/1.73 m2 * Fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment to include rising LFTs, paracentesis at less than 4 week intervals, oesophageal banding within the last 3 months, or treatment for GI bleeding within the last 6 months * Presence of a hepatocellular carcinoma or acute liver disease caused by an infection or drug toxicity.

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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

    Lake Forest, California, 92630, 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

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