NCT06812780

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

A Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389 (CAMPOLINA)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	AZD2389	Single oral dose of AZD2389 in participants from all cohorts

Timeline

• Start date: 2025-02-04
• Primary completion: 2025-09-04
• Completion: 2025-09-04
• First posted: 2025-02-06
• Last updated: 2025-09-24

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study