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

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Hepatic Impairment

Interventions: AZD5004

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (5)

Lake Forest, California, United States
Rialto, California, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States
San Antonio, Texas, United States