Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

Launched by ASTRAZENECA · Feb 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called AZD5004 to understand how it affects people with liver problems, specifically those with mild, moderate, or severe liver impairment. The researchers want to see how the body processes this medication, as well as how safe it is and how well people tolerate it. Participants in the study will be compared to healthy individuals with normal liver function. The trial is currently looking for volunteers aged 18 to 80 who meet certain health criteria.

To be eligible, participants must weigh at least 50 kg and have a body mass index (BMI) within a healthy range. Those with liver impairment will be grouped based on the severity of their condition, while healthy participants must be free from significant health issues. Throughout the study, participants will receive the medication in a single dose, and there will be regular check-ups to monitor their health and any side effects. This study aims to gather important information that can help improve treatment options for individuals with liver impairment.

Gender

ALL

Eligibility criteria

• 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.