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

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07069725

Acronym

PECHORA

Enrollment

Registered

2025-07-17

Start date

2025-05-26

Completion date

2026-07-02

Last updated

2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Cirrhosis, Liver Fibrosis

Keywords

Liver Fibrosis, Hepatic Cirrhosis

Brief 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.

Interventions

DRUGAZD2389

Doses of AZD2389 will be administrated orally

DIAGNOSTIC_TESTPET scan and radioligand

PET scan and radioligand

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Masking description

This is an open-label trial.

Intervention model description

Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies.

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: 1. Male or female (of non-childbearing potential) participant aged ≥ 20 years and willing and able to give written informed consent for participation in the trial. 2. History confirming compensated liver cirrhosis. 3. Females must have a negative pregnancy test. 4. Barrier contraceptives use by males. Key

Exclusion criteria

1. A condition that would interfere with evaluation of the trial intervention, put the participant at risk, influence the participant's ability to participate or affect the interpretation of the results of the trial. 2. Any clinically significant illness, medical or major surgical procedure or trauma prior randomization. 3. Hepatitis B , hepatitis C and/or HIV infection. 4. Significant elevations in liver blood test, MELD score \>12 and platelets \<100 x109/L g). 5. eGFR) \< 60 ml/min/1.73m2. 6. History of decompensated liver cirrhosis. 7. Any participants with an aetiology of liver cirrhosis where the Investigator considers that PET signal uptake may be impacted. 8. History of bleeding disorders and major bleeding risk. 9. History of severe dermatological disorders or wound healing. 10. Positive screening result for drugs of abuse or alcohol.

Design outcomes

Primary

Measure	Time frame	Description
Occupancy, %: percent change from baseline in uptake of FAP PET radioligand [68Ga]Ga-FAPI-46 in the liver after a single dose of AZD2389.	PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)	To examine target FAP occupancy in the liver by AZD2389 as measured with \[68Ga\]Ga-FAPI-46 PET.

Secondary

Measure	Time frame	Description
Plasma concentrations of AZD2389.	PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)	To evaluate plasma PK of AZD2389 after single doses.
AZD2389 PK parameters calculated by: the plasma concentration vs. time curve (AUC) from 0 to infinity (AUCinf) and maximum observed concentration (Cmax)	PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)	Blood sampling and analysis to evaluate PK plasma of AZD2389 after single doses.
% FAP inhibition compared to baseline in plasma.	PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)	To evaluate the plasma target engagement of AZD2389 by assessment of plasma FAP inhibition following single oral dosing.
% aTRV (for radioligand uptake).	PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)	To quantify test-retest reproducibility of radioligand \[68Ga\]Ga-FAPI-46 uptake in the liver.
ICC (for radioligand uptake).	PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)	To quantify test-retest reproducibility of radioligand \[68Ga\]Ga-FAPI-46 uptake in the liver.
Maximum possible target occupancy (Occmax).	PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)	A theoretical relationship between average concentration of AZD2389 in plasma during the PET examination and radioligand binding will be assumed to calculate maximum target occupancy, if possible, by curve fitting.
The IC50 confidence interval	PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)	A theoretical relationship between average concentration of AZD2389 in plasma during the PET examination and radioligand binding will be assumed to calculate the confidence interval associated with the IC50.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026