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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.

NCT07069725

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Liver Fibrosis, Hepatic Cirrhosis

Interventions: AZD2389, PET scan and radioligand

Countries: Sweden

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.

Eligibility overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

Stockholm, Sweden