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

Inclusion 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.