Hepatic ImpairmentPhase 1CAMPOLINANCT06812780
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389
A Phase 1 study testing AZD2389 in people with Hepatic Impairment, run by AstraZeneca at 5 sites in United States.
Trial summary
The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- AZD2389
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 Feb 2025to 4 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Hepatic:
- Participant with a diagnosis of stable hepatic impairment
- For Healthy:
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- All participants:
- Body weight ≥ 50 kg; BMI within the range of 18.0 to 42.0 kg/m2 (inclusive).
Who cannot join
- Participant has eGFR < 60 mL/minute/1.73 m2
- Positive test for HIV at screening
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity
- History of severe dermatological disorders
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Research Site
Chandler, Arizona, 85225
Research Site
Miami Lakes, Florida, 33014
Research Site
Orlando, Florida, 32809
Research Site
Rialto, California, 92377
Research Site
San Antonio, Texas, 78215
About this study
Official title: A Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389 (CAMPOLINA)
The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.
Read the detailed description
This is a single-dose, non-randomised, open-label, parallel-group study to examine the PK, fibroblast activation protein activity, safety, and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.
The study is planned to consist of:
- Cohort 1: Participants with normal hepatic function (sex-, age-, and body mass index [BMI]-matched)
- Cohort 2: Participants with mild hepatic impairment (CP A classification)
- Cohort 3: Participants with moderate hepatic impairment (CP B classification)
- Cohort 4 (Optional): Participants with severe hepatic impairment (CP C classification)
Safety, tolerability, and available plasma PK data up to 48 hours post-dose from at least 4 participants in each of the mild hepatic impairment (CP Class A) and moderate hepatic impairment (CP Class B) cohorts must have been assessed by the investigator(s), medical monitor, and sponsor prior to the decision to proceed with evaluation/recruitment of participants with severe hepatic impairment (CP Class C). Cohort 1 (normal hepatic function) will be initiated in parallel with Cohorts 2 and 3.
- Conditions
- Hepatic Impairment
- Being tested
- AZD2389
- Keywords
- Mild, Moderate, Severe, Matched Healthy Controls, Liver Fibrosis, Liver Cirrhosis
- Medical subject headings
- Lymphoma, Follicular, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2389Drug
Single oral dose of AZD2389 in participants from all cohorts
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants with normal hepatic function (sex-, age-, and body mass index [BMI]-matched) Receives: Drug: AZD2389 |
| Cohort 2 | Experimental | Participants with mild hepatic impairment (CP A classification) Receives: Drug: AZD2389 |
| Cohort 3 | Experimental | Participants with moderate hepatic impairment (CP B classification) Receives: Drug: AZD2389 |
| Cohort 4 | Experimental | Participants with severe hepatic impairment (CP C classification) Receives: Drug: AZD2389 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma PK parameter Cmax
maximum observed plasma concentration
Measured: pre-dose to 48 hours post-dose
Plasma PK parameter AUCinf
area under the concentration-time curve from zero to infinity
Measured: pre-dose to 48 hours post-dose
Plasma PK parameter AUClast
area under the concentration-time curve from zero to the last measurable concentration
Measured: pre-dose to 48 hours post-dose
Secondary outcomes (7)
Plasma PK parameter t1/2λz
half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve
Measured: pre-dose to 48 hours post-dose
Plasma PK parameter Tmax
time to reach maximum observed plasma concentration
Measured: pre-dose to 48 hours post-dose
Plasma PK parameter CL/F
apparent total body clearance of drug from plasma after extravascular administration
Measured: pre-dose to 48 hours post-dose
Plasma PK parameter Vz/F
apparent volume of distribution during the terminal phase after extravascular administration.
Measured: pre-dose to 48 hours post-dose
Urine PK parameter Ae(t1-t2)
cumulative amount of unchanged drug excreted into the urine for the interval between time 1 and time 2
Measured: pre-dose to 48 hours post-dose
Urine PK parameter CLr
renal clearance of the drug from plasma
Measured: pre-dose to 48 hours post-dose
Urine PK parameters fe(t1-t2)
fraction of the drug excreted into the urine for the interval between time 1 and time 2
Measured: pre-dose to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start4 Feb 2025
- Primary completion4 Sep 2025
- Study completion4 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be enrolled within the following groups based on their CP classification score as determined at screening: Cohort 1: Participants with normal hepatic function (sex-, age-, and body mass index \[BMI\]-matched) * Cohort 2: Participants with mild hepatic impairment (CP A classification) * Cohort 3: Participants with moderate hepatic impairment (CP B classification) * Cohort 4 (Optional): Participants with severe hepatic impairment (CP C classification)
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812780
- Sponsor's protocol ID
- D7930C00004
- Acronym
- CAMPOLINA
- Status last verified
- Sep 2025
- First submitted
- 3 Feb 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389 (CAMPOLINA)
- ClinicalTrials.gov ID
- NCT06812780
- Acronym / sponsor ID
- CAMPOLINA / D7930C00004
- Conditions
- Hepatic Impairment
- Keywords
- Mild, Moderate, Severe, Matched Healthy Controls, Liver Fibrosis, Liver Cirrhosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.
Detailed description
This is a single-dose, non-randomised, open-label, parallel-group study to examine the PK, fibroblast activation protein activity, safety, and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.
The study is planned to consist of:
- Cohort 1: Participants with normal hepatic function (sex-, age-, and body mass index [BMI]-matched)
- Cohort 2: Participants with mild hepatic impairment (CP A classification)
- Cohort 3: Participants with moderate hepatic impairment (CP B classification)
- Cohort 4 (Optional): Participants with severe hepatic impairment (CP C classification)
Safety, tolerability, and available plasma PK data up to 48 hours post-dose from at least 4 participants in each of the mild hepatic impairment (CP Class A) and moderate hepatic impairment (CP Class B) cohorts must have been assessed by the investigator(s), medical monitor, and sponsor prior to the decision to proceed with evaluation/recruitment of participants with severe hepatic impairment (CP Class C). Cohort 1 (normal hepatic function) will be initiated in parallel with Cohorts 2 and 3.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be enrolled within the following groups based on their CP classification score as determined at screening: Cohort 1: Participants with normal hepatic function (sex-, age-, and body mass index [BMI]-matched) * Cohort 2: Participants with mild hepatic impairment (CP A classification) * Cohort 3: Participants with moderate hepatic impairment (CP B classification) * Cohort 4 (Optional): Participants with severe hepatic impairment (CP C classification)
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: AZD2389Participants with normal hepatic function (sex-, age-, and body mass index [BMI]-matched) |
| Cohort 2 | Experimental | Drug: AZD2389Participants with mild hepatic impairment (CP A classification) |
| Cohort 3 | Experimental | Drug: AZD2389Participants with moderate hepatic impairment (CP B classification) |
| Cohort 4 | Experimental | Drug: AZD2389Participants with severe hepatic impairment (CP C classification) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant with a diagnosis of stable hepatic impairment
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- Body weight ≥ 50 kg; BMI within the range of 18.0 to 42.0 kg/m2 (inclusive).
Key exclusion criteria (4 listed)
- Participant has eGFR < 60 mL/minute/1.73 m2
- Positive test for HIV at screening
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity
- History of severe dermatological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD2389Single oral dose of AZD2389 in participants from all cohorts | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Plasma PK parameter Cmax
Time frame: pre-dose to 48 hours post-dose
maximum observed plasma concentration
Plasma PK parameter AUCinf
Time frame: pre-dose to 48 hours post-dose
area under the concentration-time curve from zero to infinity
Plasma PK parameter AUClast
Time frame: pre-dose to 48 hours post-dose
area under the concentration-time curve from zero to the last measurable concentration
7 secondary outcomes
Plasma PK parameter t1/2λz
Time frame: pre-dose to 48 hours post-dose
Plasma PK parameter Tmax
Time frame: pre-dose to 48 hours post-dose
Plasma PK parameter CL/F
Time frame: pre-dose to 48 hours post-dose
Plasma PK parameter Vz/F
Time frame: pre-dose to 48 hours post-dose
Urine PK parameter Ae(t1-t2)
Time frame: pre-dose to 48 hours post-dose
Urine PK parameter CLr
Time frame: pre-dose to 48 hours post-dose
Urine PK parameters fe(t1-t2)
Time frame: pre-dose to 48 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD2389 in people with Hepatic Impairment, run by AstraZeneca at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma PK parameter Cmax (time frame: pre-dose to 48 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.