Healthy ParticipantsPhase 1NCT06846528
A Study to Investigate the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole in Healthy Participants
A Phase 1 study testing AZD2389 and Itraconazole in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to assess the pharmacokinetics (PK) of AZD2389 when administered alone and in combination with itraconazole 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
- Healthy Participants
- What is being tested?
- AZD2389 and Itraconazole
- 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
- 26 Feb 2025to 23 Apr 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
- 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 postmenopausal for at least 12 months or have documentation of irreversible surgical sterilization.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
- Have a Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg.
Who cannot join
- History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- 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 illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Abnormal laboratory values, clinically important abnormalities or abnormal vital signs
- Any positive result on screening for serum Hepatitis B surface antigen/antibody, Hepatitis C, or Human Immunodeficiency Virus.
- Current smokers (within 3 months prior to screening visit) or history of alcohol and drug abuse
Show all 9Show fewer
- History of severe allergy or hypersensitivity
- Excessive intake of caffeine-containing drinks or food
- Use of drugs with enzyme inducing properties or use of any prescribed or nonprescribed medication including antacids, analgesics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Fixed Sequence Study in Healthy Participants to Assess the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole
The purpose of this study is to assess the pharmacokinetics (PK) of AZD2389 when administered alone and in combination with itraconazole in healthy participants.
Read the detailed description
This study will be an open-label, fixed sequence, Drug-Drug Interaction (DDI) study consisting of 3 periods.
The study will comprise:
- A screening period of maximum 28 days
- Period 1
- Period 2
- Period 3
- A Follow-up Visit 7 to 14 days after the last PK sample has been collected.
- Conditions
- Healthy Participants
- Being tested
- AZD2389, Itraconazole
- Keywords
- Fibroblast Activation Protein inhibitor, Advanced hepatic fibrosis, Chronic liver disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2389Drug
AZD2389 is administered orally
ItraconazoleDrug
Itraconazole is administered orally
| Study group | Role | What they receive |
|---|---|---|
| AZD2389 and Itraconazole | Experimental | AZD2389 is dosed on days 1 and 6. Itraconazole is dosed on days 3,4,5,6,7, with the dose on day 6 coming after AZD2389. Receives: Drug: AZD2389; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed drug concentration (Cmax) of AZD2389
To assess the effect of itraconazole on the Cmax of AZD2389.
Measured: Day 1 to Day 8
Area under concentration-timecurve from time zero to infinity (AUCinf) of AZD2389
To assess the effect of itraconazole on the AUCinf of AZD2389.
Measured: Day 1 to Day 8
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD2389
To assess the effect of itraconazole on the AUClast of AZD2389.
Measured: Day 1 to Day 8
Secondary outcomes (12)
Apparent total body clearance (CL/F) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole
Measured: Day 1 to Day 8
Apparent volume of distribution based on the terminal phase (Vz/F) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole
Measured: Day 1 to Day 8
Terminal elimination half-life (t1/2λz) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Measured: Day 1 to Day 8
Time to reach maximum observed concentration (tmax) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Measured: Day 1 to Day 8
Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on Cmax (RCmax) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Measured: Day 1 to Day 8
Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on AUClast (RAUClast) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Measured: Day 1 to Day 8
Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on AUCinf (RAUCinf) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Measured: Day 1 to Day 8
Renal Clearance (CLR) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Measured: Day 1 to Day 8
Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 (Ae(t1-t2)) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Measured: Day 1 to Day 8
Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 (fe(t1-t2)) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Measured: Day 1 to Day 8
Percent change from baseline in fibroblast activation protein (FAP) inhibition
To evaluate 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 itraconazole.
Measured: Day 1 to Day 8
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 itraconazole in healthy participants.
Measured: From Screening (Day -29 to Day -2) up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start26 Feb 2025
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Not applicable
- Intervention model
- Sequential
- 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
- NCT06846528
- Sponsor's protocol ID
- D7930C00005
- Status last verified
- Apr 2025
- First submitted
- 21 Feb 2025
- Last updated
- 29 Apr 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 approved.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed Sequence Study in Healthy Participants to Assess the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole
- ClinicalTrials.gov ID
- NCT06846528
- Acronym / sponsor ID
- D7930C00005
- Conditions
- Healthy Participants
- Keywords
- Fibroblast Activation Protein inhibitor, Advanced hepatic fibrosis, Chronic liver disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 26 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 assess the pharmacokinetics (PK) of AZD2389 when administered alone and in combination with itraconazole in healthy participants.
Detailed description
This study will be an open-label, fixed sequence, Drug-Drug Interaction (DDI) study consisting of 3 periods.
The study will comprise:
- A screening period of maximum 28 days
- Period 1
- Period 2
- Period 3
- A Follow-up Visit 7 to 14 days after the last PK sample has been collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD2389 and Itraconazole | Experimental | Drug: AZD2389, Drug: ItraconazoleAZD2389 is dosed on days 1 and 6. Itraconazole is dosed on days 3,4,5,6,7, with the dose on day 6 coming after AZD2389. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 postmenopausal for at least 12 months or have documentation of irreversible surgical sterilization.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
- Have a Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg.
Key exclusion criteria (9 listed)
- History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- 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 illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Abnormal laboratory values, clinically important abnormalities or abnormal vital signs
- Any positive result on screening for serum Hepatitis B surface antigen/antibody, Hepatitis C, or Human Immunodeficiency Virus.
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 is administered orally | Drug | AZD2389 and Itraconazole |
| ItraconazoleItraconazole is administered orally | Drug | AZD2389 and Itraconazole |
Primary outcome
Maximum observed drug concentration (Cmax) of AZD2389
Time frame: Day 1 to Day 8
To assess the effect of itraconazole on the Cmax of AZD2389.
Area under concentration-timecurve from time zero to infinity (AUCinf) of AZD2389
Time frame: Day 1 to Day 8
To assess the effect of itraconazole on the AUCinf of AZD2389.
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD2389
Time frame: Day 1 to Day 8
To assess the effect of itraconazole on the AUClast of AZD2389.
12 secondary outcomes
Apparent total body clearance (CL/F) of AZD2389
Time frame: Day 1 to Day 8
Apparent volume of distribution based on the terminal phase (Vz/F) of AZD2389
Time frame: Day 1 to Day 8
Terminal elimination half-life (t1/2λz) of AZD2389
Time frame: Day 1 to Day 8
Time to reach maximum observed concentration (tmax) of AZD2389
Time frame: Day 1 to Day 8
Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on Cmax (RCmax) of AZD2389
Time frame: Day 1 to Day 8
Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on AUClast (RAUClast) of AZD2389
Time frame: Day 1 to Day 8
Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on AUCinf (RAUCinf) of AZD2389
Time frame: Day 1 to Day 8
Renal Clearance (CLR) of AZD2389
Time frame: Day 1 to Day 8
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 8
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 8
Percent change from baseline in fibroblast activation protein (FAP) inhibition
Time frame: Day 1 to Day 8
Number of participants with Adverse Events (AEs)
Time frame: From Screening (Day -29 to Day -2) up to 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 29 Apr 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 approved.
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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 Itraconazole in people with 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 4 inclusion and 9 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 29 Apr 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?
Maximum observed drug concentration (Cmax) of AZD2389 (time frame: Day 1 to Day 8). 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 29 Apr 2025.