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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.

NCT ID: NCT07069725

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-26

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Liver Fibrosis Hepatic Cirrhosis

Keywords

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Liver Fibrosis Hepatic Cirrhosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label trial.

Study Groups

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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.

Group Type OTHER

PET scan and radioligand

Intervention Type DIAGNOSTIC_TEST

PET scan and radioligand

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.

Group Type EXPERIMENTAL

AZD2389

Intervention Type DRUG

Doses of AZD2389 will be administrated orally

PET scan and radioligand

Intervention Type DIAGNOSTIC_TEST

PET scan and radioligand

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.

Group Type EXPERIMENTAL

AZD2389

Intervention Type DRUG

Doses of AZD2389 will be administrated orally

PET scan and radioligand

Intervention Type DIAGNOSTIC_TEST

PET scan and radioligand

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.

Group Type EXPERIMENTAL

AZD2389

Intervention Type DRUG

Doses of AZD2389 will be administrated orally

PET scan and radioligand

Intervention Type DIAGNOSTIC_TEST

PET scan and radioligand

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.

Group Type EXPERIMENTAL

AZD2389

Intervention Type DRUG

Doses of AZD2389 will be administrated orally

PET scan and radioligand

Intervention Type DIAGNOSTIC_TEST

PET scan and radioligand

Interventions

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AZD2389

Doses of AZD2389 will be administrated orally

Intervention Type DRUG

PET scan and radioligand

PET scan and radioligand

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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The participants will perform the PET examination at the PET Centre using the radioligand [68Ga]Ga-FAPI-46.

Eligibility Criteria

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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.

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CTC Clinical Trial Consultants AB

INDUSTRY

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Solna, , Sweden

Site Status RECRUITING

Research Site

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

Other Identifiers

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D7930C00003

Identifier Type: -

Identifier Source: org_study_id