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

NCT07685600 | Not Yet Recruiting Phase 1

• 1 other identifier: D9440C00006
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy

Keywords

Pharmacokinetics; Cardiorenal diseases; Cryopyrin; Drug-drug interaction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Total body clearance (CL)

  Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16

• Apparent total body clearance (CL/F)

  Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16

• Volume of distribution during the terminal phase (Vz)

  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)

  Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16

• Terminal elimination half life (t½λz)

  Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16

Study Arms (2)

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.

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.

Drug: AZD4144; Drug: Itraconazole

Interventions

AZD4144 DRUG

AZD4144 will be administered orally.

Arm 1: Oral AZD4144

Itraconazole DRUG

Itraconazole will be administered orally.

Arm 1: Oral AZD4144; Arm 2: IV Infusion AZD4144

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): October 28, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.