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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-04

Study Completion Date

2025-09-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cohort 1

Participants with normal hepatic function (sex-, age-, and body mass index \[BMI\]-matched)

Group Type EXPERIMENTAL