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Completed

NCT Number: 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.

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Stockholm, 17176, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.
  • History confirming compensated liver cirrhosis.
  • Females must have a negative pregnancy test.
  • Barrier contraceptives use by males.

Key Exclusion Criteria:

  • 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.
  • Any clinically significant illness, medical or major surgical procedure or trauma prior randomization.
  • Hepatitis B , hepatitis C and/or HIV infection.
  • Significant elevations in liver blood test, MELD score >12 and platelets <100 x109/L g).
  • eGFR) < 60 ml/min/1.73m2.
  • History of decompensated liver cirrhosis.
  • Any participants with an aetiology of liver cirrhosis where the Investigator considers that PET signal uptake may be impacted.
  • History of bleeding disorders and major bleeding risk.
  • History of severe dermatological disorders or wound healing.
  • Positive screening result for drugs of abuse or alcohol.

Treatment and study plan

AZD2389

Drug

Doses of AZD2389 will be administrated orally

PET scan and radioligand

Diagnostic Test

PET scan and radioligand

Other names: The participants will perform the PET examination at the PET Centre using the radioligand [68Ga]Ga-FAPI-46.

Primary outcomes

  1. Occupancy, %: percent change from baseline in uptake of FAP PET radioligand [68Ga]Ga-FAPI-46 in the liver after a single dose of AZD2389.

    Time frame: 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 outcomes

  1. Plasma concentrations of AZD2389.

    Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)

    To evaluate plasma PK of AZD2389 after single doses.

  2. AZD2389 PK parameters calculated by: the plasma concentration vs. time curve (AUC) from 0 to infinity (AUCinf) and maximum observed concentration (Cmax)

    Time frame: 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.

  3. % FAP inhibition compared to baseline in plasma.

    Time frame: 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.

  4. % aTRV (for radioligand uptake).

    Time frame: 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.

  5. ICC (for radioligand uptake).

    Time frame: 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.

  6. Maximum possible target occupancy (Occmax).

    Time frame: 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.

  7. The IC50 confidence interval

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • CTC Clinical Trial Consultants AB
  • Karolinska Institutet

Registry information

Official study title

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).

Acronym: PECHORA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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