A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389

Last updated: September 23, 2025
Sponsor: AstraZeneca
Overall Status: Completed

Phase

1

Condition

Primary Biliary Cholangitis

Follicular Lymphoma

Hepatic Fibrosis

Treatment

AZD2389

Clinical Study ID

NCT06812780
D7930C00004
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.

Eligibility Criteria

Inclusion

Inclusion Criteria:

For Hepatic:

  • Participant with a diagnosis of stable hepatic impairment

For Healthy:

  • Participants who are overtly healthy as determined by medical evaluation includingmedical history, physical examination, and laboratory tests.

All participants:

  • Body weight ≥ 50 kg; BMI within the range of 18.0 to 42.0 kg/m2 (inclusive).

Exclusion

Exclusion Criteria:

  • Participant has eGFR < 60 mL/minute/1.73 m2

  • Positive test for HIV at screening

  • History of severe allergy/hypersensitivity or ongoing clinically importantallergy/hypersensitivity

  • History of severe dermatological disorders

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: AZD2389
Phase: 1
Study Start date:
February 04, 2025
Estimated Completion Date:
September 04, 2025

Study Description

This is a single-dose, non-randomised, open-label, parallel-group study to examine the PK, fibroblast activation protein activity, safety, and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.

The study is planned to consist of:

  • Cohort 1: Participants with normal hepatic function (sex-, age-, and body mass index [BMI]-matched)

  • Cohort 2: Participants with mild hepatic impairment (CP A classification)

  • Cohort 3: Participants with moderate hepatic impairment (CP B classification)

  • Cohort 4 (Optional): Participants with severe hepatic impairment (CP C classification)

Safety, tolerability, and available plasma PK data up to 48 hours post-dose from at least 4 participants in each of the mild hepatic impairment (CP Class A) and moderate hepatic impairment (CP Class B) cohorts must have been assessed by the investigator(s), medical monitor, and sponsor prior to the decision to proceed with evaluation/recruitment of participants with severe hepatic impairment (CP Class C). Cohort 1 (normal hepatic function) will be initiated in parallel with Cohorts 2 and 3.

Connect with a study center

  • Research Site

    Chandler, Arizona 85225
    United States

    Site Not Available

  • Research Site

    Chandler 5289282, Arizona 5551752 85225
    United States

    Site Not Available

  • Research Site

    Rialto, California 92377
    United States

    Site Not Available

  • Research Site

    Rialto 5387288, California 5332921 92377
    United States

    Site Not Available

  • Research Site

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Research Site

    Orlando, Florida 32809
    United States

    Site Not Available

  • Research Site

    Miami Lakes 4164186, Florida 4155751 33014
    United States

    Site Not Available

  • Research Site

    Orlando 4167147, Florida 4155751 32809
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Research Site

    San Antonio 4726206, Texas 4736286 78215
    United States

    Site Not Available

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