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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.
Conditions: Liver Fibrosis, Hepatic Cirrhosis
Sex: All
Ages: 20 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 7
Sponsor: AstraZeneca
Location: Research Site Stockholm
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.
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 \
Source: ClinicalTrials.gov (NCT07069725). StuddyBuddy aggregates publicly available trial information.
