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

Last updated: March 14, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1

Condition

Primary Biliary Cholangitis

Treatment

AZD5004

Clinical Study ID

NCT06813781
D7260C00011
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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 Criteria

Inclusion

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 hepaticfunction:

  • Participant must be stable on a concomitant medication and/or treatment regimen forat 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 havea Child-Pugh score of 7 to 9, Group 3 (severe) must have a Child-Pugh score of 10 to
  • Participant must have a diagnosis of chronic (≥ 6 months) and stable hepaticimpairment (eg, no clinically significant change in signs, symptoms, or laboratoryparameters of hepatic disease status within 30 days prior to study screening

Exclusion

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 theresting 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 stronglyvarying or worsening of clinical and/or laboratory signs of hepatic impairment toinclude rising LFTs, paracentesis at less than 4 week intervals, oesophageal bandingwithin 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 infectionor drug toxicity.

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: AZD5004
Phase: 1
Study Start date:
December 19, 2024
Estimated Completion Date:
October 21, 2025

Study 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, or severe hepatic impairment compared with participants with normal hepatic function.

Participants will be enrolled within the following groups based on their Child Pugh classification score as determined at screening:

Group 1: Participants with mild hepatic impairment (Child Pugh Class A, score of 5 or 6).

Group 2: Participants with moderate hepatic impairment (Child Pugh Class B, score of 7 to 9).

Group 3: Participants with severe hepatic impairment (Child Pugh Class C, score of 10 to 15).

Group 4: Participants with normal hepatic function matched on a group level regarding sex, age, and body weight to the impaired participants.

Connect with a study center

  • Research Site

    Lake Forest, California 92630
    United States

    Active - Recruiting

  • Research Site

    Rialto, California 92377
    United States

    Active - Recruiting

  • Research Site

    Orlando, Florida 32809
    United States

    Active - Recruiting

  • Research Site

    San Antonio, Texas 78215
    United States

    Active - Recruiting

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