RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

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

Condition
Hepatic Impairment
Intervention / Treatment

-

Contacts and Locations

Lake Forest

Research Site, Lake Forest, California, United States, 92630

Rialto

Research Site, Rialto, California, United States, 92377

Orlando

Research Site, Orlando, Florida, United States, 32809

San Antonio

Research Site, San Antonio, Texas, United States, 78215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2025-10-22