HealthyPhase 1NCT07685600
Investigating the Effect of Itraconazole on the Pharmacokinetics of AZD4144 in Healthy Participants
A Phase 1 study testing AZD4144 and Itraconazole in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of the study is to assess the pharmacokinetics (PK) of AZD4144 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
- What is being tested?
- AZD4144 and Itraconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jul 2026to 22 Oct 2026
- 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/or female participants with suitable veins for cannulation or repeated venipuncture.
- Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive, and body weight of at least 50 kg.
- Female participants of childbearing potential must have a negative serum or urine pregnancy test and must agree to use highly effective contraception throughout the study and follow-up period.
- Male participants must agree to use adequate contraception and refrain from sperm donation during the study and for the protocol-specified period after the last dose.
Who cannot join
- Any clinically significant disease or medical condition that may interfere with study participation or interpretation of results.
- History or presence of gastrointestinal, hepatic, renal or any other condition known to interfere absorption, distribution, metabolism, or excretion of study drugs.
- Any clinically important illness, medical/surgical procedure, or trauma.
- Active systemic bacterial, viral, or fungal infection.
- Clinically significant serious active or chronic infections.
- Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
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- Concomitant immunosuppressive, steroid treatment.
- Clinically significant abnormalities in physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory assessments.
- Known hypersensitivity or allergy to AZD4144, itraconazole, or any excipients of the study interventions.
- Positive screening test for drugs of abuse, alcohol, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomised, Two Arm, Fixed Sequence Study in Healthy Participants to Assess the Pharmacokinetics of AZD4144 When Administered Alone and in Combination With Itraconazole
The purpose of the study is to assess the pharmacokinetics (PK) of AZD4144 when administered alone and in combination with itraconazole in healthy participants.
Read the detailed description
This is an open-label, randomised, two arm, 3 period, fixed sequence study in healthy participants.
The study will include two parallel, independent arms with one arm evaluating oral administration of AZD4144 and the other evaluating AZD4144 administered as an intravenous (IV) infusion.
Each study arm will comprise of:
- A screening period of up to 28 days.
- Three treatment periods during which participants will receive AZD4144 alone, itraconazole alone, and AZD4144 in combination with itraconazole.
- A final follow-up visit.
- Conditions
- Healthy
- Being tested
- AZD4144, Itraconazole
- Keywords
- Pharmacokinetics, Cardiorenal diseases, Cryopyrin, Drug-drug interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4144Drug
AZD4144 will be administered orally.
AZD4144Drug
AZD4144 will be administered as an IV infusion.
ItraconazoleDrug
Itraconazole will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Oral AZD4144 | Experimental | In Period 1, participants will receive a single oral dose of AZD4144 on Day 1. In Period 2, participants will receive itraconazole alone, administered orally, with twice-daily dosing on Day 7 followed by once-daily dosing on Days 8 and 9. In Period 3, participants will receive a single oral dose of AZD4144 on Day 10 in combination with once-daily oral itraconazole till Day 15. Receives: Drug: AZD4144; Drug: Itraconazole |
| Arm 2: IV Infusion AZD4144 | Experimental | In Period 1, participants will receive a single IV infusion of AZD4144 on Day 1. In Period 2, participants will receive itraconazole alone, administered orally, with twice-daily dosing on Day 7 followed by once-daily dosing on Days 8 and 9. In Period 3, participants will receive a single IV infusion of AZD4144 on Day 10 in combination with once-daily oral itraconazole till Day 15. Receives: Drug: AZD4144; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under concentration time curve from time 0 to infinity (AUCinf)
To assess the effect of itraconazole on the PK (AUCinf) of AZD4144
Measured: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
To assess the effect of itraconazole on the PK (AUClast) of AZD4144
Measured: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Maximum observed drug concentration (Cmax)
To assess the effect of itraconazole on the PK (Cmax) of AZD4144
Measured: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Secondary outcomes (6)
Total body clearance (CL)
To describe the PK (CL) of AZD4144 when administered alone, and in combination with itraconazole
Measured: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Apparent total body clearance (CL/F)
To describe the PK (CL/F) of AZD4144 when administered alone, and in combination with itraconazole
Measured: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Volume of distribution during the terminal phase (Vz)
To describe the PK (Vz) of AZD4144 when administered alone, and in combination with itraconazole
Measured: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Apparent volume of distribution based on the terminal phase (Vz/F)
To describe the PK (Vz/F) of AZD4144 when administered alone, and in combination with itraconazole
Measured: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Terminal elimination half life (t½λz)
To describe the PK (t½λz) of AZD4144 when administered alone, and in combination with itraconazole
Measured: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Time to reach maximum observed concentration (tmax)
To describe the PK (tmax) of AZD4144 when administered alone, and in combination with itraconazole
Measured: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start30 Jul 2026
- Primary completion22 Oct 2026
- Study completion22 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685600
- Sponsor's protocol ID
- D9440C00006
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised, Two Arm, Fixed Sequence Study in Healthy Participants to Assess the Pharmacokinetics of AZD4144 When Administered Alone and in Combination With Itraconazole
- ClinicalTrials.gov ID
- NCT07685600
- Acronym / sponsor ID
- D9440C00006
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Cardiorenal diseases, Cryopyrin, Drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 22 Oct 2026 (actual)
- Study completion
- 22 Oct 2026 (actual)
- First posted
- 6 Jul 2026 (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 the study is to assess the pharmacokinetics (PK) of AZD4144 when administered alone and in combination with itraconazole in healthy participants.
Detailed description
This is an open-label, randomised, two arm, 3 period, fixed sequence study in healthy participants.
The study will include two parallel, independent arms with one arm evaluating oral administration of AZD4144 and the other evaluating AZD4144 administered as an intravenous (IV) infusion.
Each study arm will comprise of:
- A screening period of up to 28 days.
- Three treatment periods during which participants will receive AZD4144 alone, itraconazole alone, and AZD4144 in combination with itraconazole.
- A final follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Oral AZD4144 | Experimental | Drug: AZD4144, Drug: ItraconazoleIn Period 1, participants will receive a single oral dose of AZD4144 on Day 1. In Period 2, participants will receive itraconazole alone, administered orally, with twice-daily dosing on Day 7 followed by once-daily dosing on Days 8 and 9. In Period 3, participants will receive a single oral dose of AZD4144 on Day 10 in combination with once-daily oral itraconazole till Day 15. |
| Arm 2: IV Infusion AZD4144 | Experimental | Drug: AZD4144, Drug: ItraconazoleIn Period 1, participants will receive a single IV infusion of AZD4144 on Day 1. In Period 2, participants will receive itraconazole alone, administered orally, with twice-daily dosing on Day 7 followed by once-daily dosing on Days 8 and 9. In Period 3, participants will receive a single IV infusion of AZD4144 on Day 10 in combination with once-daily oral itraconazole till Day 15. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and/or female participants with suitable veins for cannulation or repeated venipuncture.
- Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive, and body weight of at least 50 kg.
- Female participants of childbearing potential must have a negative serum or urine pregnancy test and must agree to use highly effective contraception throughout the study and follow-up period.
- Male participants must agree to use adequate contraception and refrain from sperm donation during the study and for the protocol-specified period after the last dose.
Key exclusion criteria (10 listed)
- Any clinically significant disease or medical condition that may interfere with study participation or interpretation of results.
- History or presence of gastrointestinal, hepatic, renal or any other condition known to interfere absorption, distribution, metabolism, or excretion of study drugs.
- Any clinically important illness, medical/surgical procedure, or trauma.
- Active systemic bacterial, viral, or fungal infection.
- Clinically significant serious active or chronic infections.
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 |
|---|---|---|
| AZD4144AZD4144 will be administered orally. | Drug | Arm 1: Oral AZD4144 |
| AZD4144AZD4144 will be administered as an IV infusion. | Drug | Arm 2: IV Infusion AZD4144 |
| ItraconazoleItraconazole will be administered orally. | Drug | Arm 1: Oral AZD4144, Arm 2: IV Infusion AZD4144 |
Primary outcome
Area under concentration time curve from time 0 to infinity (AUCinf)
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
To assess the effect of itraconazole on the PK (AUCinf) of AZD4144
Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
To assess the effect of itraconazole on the PK (AUClast) of AZD4144
Maximum observed drug concentration (Cmax)
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
To assess the effect of itraconazole on the PK (Cmax) of AZD4144
6 secondary outcomes
Total body clearance (CL)
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Apparent total body clearance (CL/F)
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Volume of distribution during the terminal phase (Vz)
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Terminal elimination half life (t½λz)
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Time to reach maximum observed concentration (tmax)
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
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 3 Nov 2026.
- 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 AZD4144 and Itraconazole in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
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 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 3 Nov 2026. 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 Kingdom. 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?
Area under concentration time curve from time 0 to infinity (AUCinf) (time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16). 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 3 Nov 2026.