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

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with mild, moderate, and severe hepatic impairment compared with participants with normal hepatic function.

Key facts

Study ID

NCT06813781

Run by

AstraZeneca

People needed

33

Starts

2024-12-19

Expected to finish

2025-10-02

Last updated by the study team

2025-10-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Lake Forest, California, United States
• Research Site — Rialto, California, United States
• Research Site — Miami Lakes, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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