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. - PECHORA
Study identifier:D7930C00003
ClinicalTrials.gov identifier:NCT07069725
EudraCT identifier:N/A
CTIS identifier:2024-517605-91-00
Recruiting
Official Title
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).
Medical condition
Liver Fibrosis
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD2389
Sex
All
Estimated Enrollment
12
Study type
Interventional
Age
20 Years - n/a
Date
Study Start Date: 26 May 2025
Estimated Primary Completion Date: 19 Feb 2026
Estimated Study Completion Date: 19 Feb 2026
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Clinical Trial Consultants (CTC), Karolinska Institutet
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Other: Part A In Part A, eligible participants (screening Visit 1) will return to the trial site for pre-assessments, confirmation of eligibility criteria, blood sampling for FAP concentration analysis (at the trial site), and the first PET examination (screening Visit 2). The participants will perform the PET examination at the PET Centre using the radioligand [68Ga]Ga-FAPI-46. Depending on the results of the initial PET examination, participants of Part A may be invited to continue the trial in Part B. In such a case they will participate in a total of 3 PET examinations, not exceeding predefined radiation exposure limits. If they do not participate further, they will complete the trial with a follow-up visit (Visit 3, telephone call) 7 days (±2 days) after the PET examination. | Diagnostic Test: PET scan and radioligand PET scan and radioligand Other Name: The participants will perform the PET examination at the PET Centre using the radioligand [68Ga]Ga-FAPI-46. |
| Experimental: Part B1 In Part B1, eligible participants who completed the first PET scan at the screening visit and/or Part A will return to the trial site for blood sampling for FAP concentration analysis and the second PET examination on Day 1 (Visit 3) using the radioligand [68Ga]Ga-FAPI-46. At Visit 4, on Day 7 (±2 days), participants will receive a single oral dose of AZD2389. After AZD2389 administration, the third PET examination will be performed at the PET Centre followed by blood sampling for PK analysis and FAP activity, after which the participants will return to the trial site for further follow-up and safety monitoring. The participants will then be discharged from the trial site. Two follow up visits will occur after administration of AZD2389. Visit 5 (7 days [±2 days]) and Visit 6 (30 days[+7 days]) will monitor for safety and follow-up of AEs. | Drug: AZD2389 Doses of AZD2389 will be administrated orally Diagnostic Test: PET scan and radioligand PET scan and radioligand Other Name: The participants will perform the PET examination at the PET Centre using the radioligand [68Ga]Ga-FAPI-46. |
| Experimental: Part B2 In Part B2, eligible participants who completed the first PET scan at the screening visit and/or Part A will return to the trial site for blood sampling for FAP concentration analysis and the second PET examination on Day 1 (Visit 3) using the radioligand [68Ga]Ga-FAPI-46. At Visit 4, on Day 7 (±2 days), participants will receive a single oral dose of AZD2389. After AZD2389 administration, the third PET examination will be performed at the PET Centre followed by blood sampling for PK analysis and FAP activity, after which the participants will return to the trial site for further follow-up and safety monitoring. The participants will then be discharged from the trial site. Two follow up visits will occur after administration of AZD2389. Visit 5 (7 days [±2 days]) and Visit 6 (30 days[+7 days]) will monitor for safety and follow-up of AEs. | Drug: AZD2389 Doses of AZD2389 will be administrated orally Diagnostic Test: PET scan and radioligand PET scan and radioligand Other Name: The participants will perform the PET examination at the PET Centre using the radioligand [68Ga]Ga-FAPI-46. |
| Experimental: Part B3 In Part B3, eligible participants who completed the first PET scan at the screening visit and/or Part A will return to the trial site for blood sampling for FAP concentration analysis and the second PET examination on Day 1 (Visit 3) using the radioligand [68Ga]Ga-FAPI-46. At Visit 4, on Day 7 (±2 days), participants will receive a single oral dose of AZD2389. After AZD2389 administration, the third PET examination will be performed at the PET Centre followed by blood sampling for PK analysis and FAP activity, after which the participants will return to the trial site for further follow-up and safety monitoring. The participants will then be discharged from the trial site. Two follow up visits will occur after administration of AZD2389. Visit 5 (7 days [±2 days]) and Visit 6 (30 days[+7 days]) will monitor for safety and follow-up of AEs. | Drug: AZD2389 Doses of AZD2389 will be administrated orally Diagnostic Test: PET scan and radioligand PET scan and radioligand Other Name: The participants will perform the PET examination at the PET Centre using the radioligand [68Ga]Ga-FAPI-46. |
| Experimental: Part C In Part C (optional), participants attend the trial site during Visit 1 (screening, Day-35 to Day-14) to undergo an eligibility check. At Visit 2, the first PET examination with radioligand will be performed at least 5 days before IMP administration. At Visit 3 (Day 1), participants receive a single dose AZD2389, then undergo a second PET examination using the radioligand on Day 2, along with blood sampling for PK analysis and FAP activity. At Visit 4 (Day 8 ±2 days), participants will be admitted to the trial site for a second single dose, then undergo a third PET examination using the radioligand on Day 9, along with blood sampling. At Visit 5 (7 days ±2 days after the PET examination on Visit 4) and Visit 6 (30 days [+7 days]) after the drug administration on Visit 4), follow-up visits at the trial site take place for safety monitoring and follow-up of any AEs. | Drug: AZD2389 Doses of AZD2389 will be administrated orally Diagnostic Test: PET scan and radioligand PET scan and radioligand Other Name: The participants will perform the PET examination at the PET Centre using the radioligand [68Ga]Ga-FAPI-46. |
