Investigating the Effect of Itraconazole on the Pharmacokinetics of AZD4144 in Healthy Participants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD4144; Drug: AZD4144; Drug: Itraconazole

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:

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Oral AZD4144; 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.	Drug: AZD4144; AZD4144 will be administered orally.; Drug: AZD4144; AZD4144 will be administered as an IV infusion.; Drug: Itraconazole; Itraconazole will be administered orally.
Experimental: Arm 2: IV Infusion AZD4144; 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.	Drug: AZD4144; AZD4144 will be administered orally.; Drug: AZD4144; AZD4144 will be administered as an IV infusion.; Drug: Itraconazole; Itraconazole will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under concentration time curve from time 0 to infinity (AUCinf)	To assess the effect of itraconazole on the PK (AUCinf) of AZD4144	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	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	Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total body clearance (CL)	To describe the PK (CL) of AZD4144 when administered alone, and in combination with itraconazole	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	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	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	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	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	Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): October 28, 2026

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Drug-drug interaction; Cryopyrin; Cardiorenal diseases
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Triazoles; Piperazines; Itraconazole
• Other Study ID Numbers: D9440C00006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No