RecruitingPhase 1NCT07069725
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.
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).
Sponsor
AstraZeneca
Enrollment
12 participants
Start Date
May 26, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 20 Years
Inclusion Criteria4
- 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 Criteria10
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGAZD2389
Doses of AZD2389 will be administrated orally
DIAGNOSTIC_TESTPET scan and radioligand
PET scan and radioligand
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07069725
Related Trials
Rapid Breath-hold Quantitative Macromolecular Proton Fraction Imaging for Liver Fibrosis
NCT044291001 location
Incidence of Liver Disease-Related Outcomes in People With HIV
NCT069403752 locations
MR Elastography for Assessing Liver Fibrosis in Chronic Hepatitis B
NCT067790581 location
City-Hospital Collaboration for Early Detection of Liver Fibrosis in Primary Care: A Secondary Prevention Project in the Grenoble Health Area
NCT070310892 locations
Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans
NCT055261441 location