Advanced Chronic Liver DiseasePhase 1NCT06974565
A Study to Investigate the Pharmacokinetics of AZD2389 in Healthy Participants When Administered Alone and in Combination With Quinidine
A Phase 1 study testing AZD2389 and Quinidine in people with Advanced Chronic Liver Disease and Healthy Participants, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to assess the pharmacokinetics (PK) and safety of AZD2389 when administered alone and in combination with quinidine in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Chronic Liver Disease, Healthy Participants
- What is being tested?
- AZD2389 and Quinidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2025to 18 Jul 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of non-childbearing potential must be confirmed at the Screening Visit.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods from the time of first administration of study intervention administration until 3 months after the study Follow-up Visit.
- Have a body mass index between 18 and 32 kg/m2, inclusive, and weigh at least 50 kg at the Screening Visit.
Who cannot join
- History of any clinically important disease or disorder.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important abnormalities in hematology, clinical chemistry, urinalysis, coagulation results or other laboratory values and vital signs.
- Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV).
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG) at Screening.
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
Show all 10Show fewer
- Current smokers or those who have smoked or used nicotine products within the previous 3 months prior to screening.
- Positive screen for drugs of abuse, or alcohol or cotinine at Screening.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
- History of hypersensitivity to dipeptidyl peptidase 4 (DPP4) inhibitors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Cross-over, Single Dose Study in Healthy Participants to Assess the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Quinidine
The purpose of this study is to assess the pharmacokinetics (PK) and safety of AZD2389 when administered alone and in combination with quinidine in healthy participants.
Read the detailed description
This is a 2-way cross-over study to evaluate the effect of quinidine on the PK of AZD2389.
The study will include 2 Treatments - Treatment A - AZD2389 Treatment B - AZD2389 + quinidine
The study will comprise -
- A Screening Period of maximum 28 days.
- Period 1: single dose administration of Treatment A or Treatment B on Day 1. Period 2 will start after a washout period of at least 7 days.
- Period 2: single dose of alternate treatment on Day 8.
- A Follow-up Visit: participants will return for a Follow-up Visit, 7 to 14 days after the last AZD2389 PK sample in Period 2.
Participants will be randomized to one of the 2 treatment sequences -
- Sequence AB: Treatment A in Period 1, Treatment B in Period 2.
- Sequence BA: Treatment B in Period 1, Treatment A in Period 2.
- Being tested
- AZD2389, Quinidine
- Keywords
- Hepatic Fibrosis, Fibroblast Activation Protein Inhibitor
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2389Drug
AZD2389 will be administered orally.
QuinidineDrug
Quinidine will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Sequence AB | Experimental | Participants will receive a single dose of Treatment A (AZD2389) in Period 1 and a single dose of Treatment B (AZD2389 + quinidine) in Period 2. Receives: Drug: AZD2389; Drug: Quinidine |
| Sequence BA | Experimental | Participants will receive a single dose of Treatment B (AZD2389 + quinidine) in Period 1 and a single dose of Treatment A (AZD2389) in Period 2. Receives: Drug: AZD2389; Drug: Quinidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Test treatment (AZD2389 + quinidine) to Reference treatment (AZD2389) based on maximum observed plasma concentration (RCmax)
To assess the effect of quinidine on the PK of AZD2389.
Measured: Day 1 to Day 10
Ratio of Test treatment (AZD2389 + quinidine) to Reference treatment (AZD2389) based on area under concentration-time curve from time 0 to infinity (RAUCinf)
To assess the effect of quinidine on the PK of AZD2389.
Measured: Day 1 to Day 10
Ratio of Test treatment (AZD2389 + quinidine) to Reference treatment (AZD2389) based on area under concentration-time curve from time 0 to the last quantifiable concentration (RAUClast)
To assess the effect of quinidine on the PK of AZD2389.
Measured: Day 1 to Day 10
Secondary outcomes (12)
Apparent total body clearance (CL/F) of AZD2389
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Measured: Day 1 to Day 10
Volume of distribution (apparent) following extravascular administration (based on terminal phase) (Vz/F) of AZD2389
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Measured: Day 1 to Day 10
Terminal elimination half-life (t1/2λz) of AZD2389
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Measured: Day 1 to Day 10
Time to reach maximum observed concentration (tmax) of AZD2389
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Measured: Day 1 to Day 10
Maximum observed plasma concentration (Cmax) of AZD2389
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Measured: Day 1 to Day 10
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD2389
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Measured: Day 1 to Day 10
Area under concentration-time curve from time zero to infinity (AUCinf) of AZD2389
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Measured: Day 1 to Day 10
Renal Clearance (CLR) of AZD2389 from plasma
To assess the urine PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Measured: Day 1 to Day 10
Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 (fe[t1-t2]) of AZD2389
To assess the urine PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Measured: Day 1 to Day 10
Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 (Ae[t1-t2]) of AZD2389
To assess the urine PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Measured: Day 1 to Day 10
Percent change from baseline in fibroblast activation protein (FAP) inhibition
To assess the pharmacodynamics (PD) of AZD2389 by assessment of inhibition of FAP activity in plasma after single oral dose of AZD2389 alone or in combination with quinidine.
Measured: Baseline, Day 1 to Day 10
Number of participants with Adverse Events (AEs)
To assess the safety and tolerability of a single oral dose of AZD2389 alone or in combination with quinidine in healthy participants.
Measured: From Screening (Day -28 to Day -2) to Follow-up visit (upto 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start12 May 2025
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Chronic Liver DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974565
- Sponsor's protocol ID
- D7930C00006
- Status last verified
- Jul 2025
- First submitted
- 8 May 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Cross-over, Single Dose Study in Healthy Participants to Assess the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Quinidine
- ClinicalTrials.gov ID
- NCT06974565
- Acronym / sponsor ID
- D7930C00006
- Keywords
- Hepatic Fibrosis, Fibroblast Activation Protein Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 12 May 2025 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 16 May 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 assess the pharmacokinetics (PK) and safety of AZD2389 when administered alone and in combination with quinidine in healthy participants.
Detailed description
This is a 2-way cross-over study to evaluate the effect of quinidine on the PK of AZD2389.
The study will include 2 Treatments - Treatment A - AZD2389 Treatment B - AZD2389 + quinidine
The study will comprise -
- A Screening Period of maximum 28 days.
- Period 1: single dose administration of Treatment A or Treatment B on Day 1. Period 2 will start after a washout period of at least 7 days.
- Period 2: single dose of alternate treatment on Day 8.
- A Follow-up Visit: participants will return for a Follow-up Visit, 7 to 14 days after the last AZD2389 PK sample in Period 2.
Participants will be randomized to one of the 2 treatment sequences -
- Sequence AB: Treatment A in Period 1, Treatment B in Period 2.
- Sequence BA: Treatment B in Period 1, Treatment A in Period 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence AB | Experimental | Drug: AZD2389, Drug: QuinidineParticipants will receive a single dose of Treatment A (AZD2389) in Period 1 and a single dose of Treatment B (AZD2389 + quinidine) in Period 2. |
| Sequence BA | Experimental | Drug: AZD2389, Drug: QuinidineParticipants will receive a single dose of Treatment B (AZD2389 + quinidine) in Period 1 and a single dose of Treatment A (AZD2389) in Period 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of non-childbearing potential must be confirmed at the Screening Visit.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods from the time of first administration of study intervention administration until 3 months after the study Follow-up Visit.
- Have a body mass index between 18 and 32 kg/m2, inclusive, and weigh at least 50 kg at the Screening Visit.
Key exclusion criteria (10 listed)
- History of any clinically important disease or disorder.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important abnormalities in hematology, clinical chemistry, urinalysis, coagulation results or other laboratory values and vital signs.
- Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV).
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG) at Screening.
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 |
|---|---|---|
| AZD2389AZD2389 will be administered orally. | Drug | Sequence AB, Sequence BA |
| QuinidineQuinidine will be administered orally. | Drug | Sequence AB, Sequence BA |
Primary outcome
Ratio of Test treatment (AZD2389 + quinidine) to Reference treatment (AZD2389) based on maximum observed plasma concentration (RCmax)
Time frame: Day 1 to Day 10
To assess the effect of quinidine on the PK of AZD2389.
Ratio of Test treatment (AZD2389 + quinidine) to Reference treatment (AZD2389) based on area under concentration-time curve from time 0 to infinity (RAUCinf)
Time frame: Day 1 to Day 10
To assess the effect of quinidine on the PK of AZD2389.
Ratio of Test treatment (AZD2389 + quinidine) to Reference treatment (AZD2389) based on area under concentration-time curve from time 0 to the last quantifiable concentration (RAUClast)
Time frame: Day 1 to Day 10
To assess the effect of quinidine on the PK of AZD2389.
12 secondary outcomes
Apparent total body clearance (CL/F) of AZD2389
Time frame: Day 1 to Day 10
Volume of distribution (apparent) following extravascular administration (based on terminal phase) (Vz/F) of AZD2389
Time frame: Day 1 to Day 10
Terminal elimination half-life (t1/2λz) of AZD2389
Time frame: Day 1 to Day 10
Time to reach maximum observed concentration (tmax) of AZD2389
Time frame: Day 1 to Day 10
Maximum observed plasma concentration (Cmax) of AZD2389
Time frame: Day 1 to Day 10
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD2389
Time frame: Day 1 to Day 10
Area under concentration-time curve from time zero to infinity (AUCinf) of AZD2389
Time frame: Day 1 to Day 10
Renal Clearance (CLR) of AZD2389 from plasma
Time frame: Day 1 to Day 10
Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 (fe[t1-t2]) of AZD2389
Time frame: Day 1 to Day 10
Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 (Ae[t1-t2]) of AZD2389
Time frame: Day 1 to Day 10
Percent change from baseline in fibroblast activation protein (FAP) inhibition
Time frame: Baseline, Day 1 to Day 10
Number of participants with Adverse Events (AEs)
Time frame: From Screening (Day -28 to Day -2) to Follow-up visit (upto 8 weeks)
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 25 Jul 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
1 site 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 and Quinidine in people with Advanced Chronic Liver Disease and Healthy Participants, run by AstraZeneca at 1 site 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 5 inclusion and 10 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 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Ratio of Test treatment (AZD2389 + quinidine) to Reference treatment (AZD2389) based on maximum observed plasma concentration (RCmax) (time frame: Day 1 to Day 10). 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 25 Jul 2025.