Research Site
Stockholm, 17176, Sweden
NCT Number: NCT07069725
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.
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Notify Me20 year and older
All sexes
Interventional
Phase 1
Stockholm, 17176, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Doses of AZD2389 will be administrated orally
PET scan and radioligand
Other names: The participants will perform the PET examination at the PET Centre using the radioligand [68Ga]Ga-FAPI-46.
Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
To examine target FAP occupancy in the liver by AZD2389 as measured with [68Ga]Ga-FAPI-46 PET.
Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
To evaluate plasma PK of AZD2389 after single doses.
Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
Blood sampling and analysis to evaluate PK plasma of AZD2389 after single doses.
Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
To evaluate the plasma target engagement of AZD2389 by assessment of plasma FAP inhibition following single oral dosing.
Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
To quantify test-retest reproducibility of radioligand [68Ga]Ga-FAPI-46 uptake in the liver.
Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
To quantify test-retest reproducibility of radioligand [68Ga]Ga-FAPI-46 uptake in the liver.
Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
A theoretical relationship between average concentration of AZD2389 in plasma during the PET examination and radioligand binding will be assumed to calculate maximum target occupancy, if possible, by curve fitting.
Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
A theoretical relationship between average concentration of AZD2389 in plasma during the PET examination and radioligand binding will be assumed to calculate the confidence interval associated with the IC50.
AstraZeneca
Industry
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).
Acronym: PECHORA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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