RecruitingPhase 1

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.

Sweden12 participantsStarted 2025-05-26

Plain-language 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.

Who can participate

Age range20 Years

SexALL

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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.

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.

What they're measuring

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

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

Trial details

NCT IDNCT07069725

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-13

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

View on ClinicalTrials.gov More Liver Fibrosis trials