Overview
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.
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.
Eligibility
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 <140 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.