NCT07069725

The Phase 1, Open-label, PET Trial Designed to Investigate the Effect of AZD2389 on FAP Occupancy in the Liver in Participants With Advanced Liver Fibrosis.

A Phase 1, Open-label Positron Emission Tomography Trial to Assess Changes in Liver Uptake of [68Ga]Ga-FAPI-46 Following Oral Administration of Single Doses of AZD2389 to Patients With Advanced Liver Fibrosis (PECHORA).

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, open-label, PET trial. The study is designed to investigate the effect of AZD2389 on FAP occupancy in the liver in participants with advanced liver fibrosis.

Detailed description

This is a phase 1, open-label, PET trial in male and female patients with advanced liver fibrosis. The trial will consist of up to 3 sequential panels: Part A (Pilot panel), Part B (Main panel - 3 dose levels of AZD2389, 2 participants per dose level.), and Part C (optional panel). The design of the trial is adaptive and adjustments in time points and/or number of assessments and samples can be made during the course of the trial.

Conditions

• Liver Fibrosis
• Hepatic Cirrhosis

Interventions

Type	Name	Description
DRUG	AZD2389	Doses of AZD2389 will be administrated orally
DIAGNOSTIC_TEST	PET scan and radioligand	PET scan and radioligand

Timeline

• Start date: 2025-05-26
• Primary completion: 2026-05-26
• Completion: 2026-05-26
• First posted: 2025-07-17
• Last updated: 2026-02-19

Locations

2 sites across 1 country: Sweden