Liver impairment study tests drug processing in 33 volunteers
NCT ID NCT06813781
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
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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 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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Other studies related to the condition(s) this trial covers.
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