The purpose of the study is to assess the pharmacokinetics (PK) of AZD4144 when administered alone and in combination with itraconazole in healthy participants.

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:

1. A screening period of up to 28 days.
2. Three treatment periods during which participants will receive AZD4144 alone, itraconazole alone, and AZD4144 in combination with itraconazole.
3. A final follow-up visit.

Inclusion Criteria:

1. Healthy male and/or female participants with suitable veins for cannulation or repeated venipuncture.
2. Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive, and body weight of at least 50 kg.
3. 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.
4. 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.

Exclusion Criteria:

1. Any clinically significant disease or medical condition that may interfere with study participation or interpretation of results.
2. History or presence of gastrointestinal, hepatic, renal or any other condition known to interfere absorption, distribution, metabolism, or excretion of study drugs.
3. Any clinically important illness, medical/surgical procedure, or trauma.
4. Active systemic bacterial, viral, or fungal infection.
5. Clinically significant serious active or chronic infections.
6. Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
7. Concomitant immunosuppressive, steroid treatment.
8. Clinically significant abnormalities in physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory assessments.
9. Known hypersensitivity or allergy to AZD4144, itraconazole, or any excipients of the study interventions.
10. Positive screening test for drugs of abuse, alcohol, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).

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.

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.