Investigating the effect of itraconazole on the pharmacokinetics of AZD4144 in healthy participants

Study identifier:D9440C00006

ClinicalTrials.gov identifier:NCT07685600

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

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

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD4144, Itraconazole

Sex

All

Estimated Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 30 Jul 2026

Estimated Primary Completion Date: 28 Oct 2026

Estimated Study Completion Date: 28 Oct 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 May 2026 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
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: 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 as an IV infusion. Drug: Itraconazole Itraconazole will be administered orally.

Arms

Assigned Interventions

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: 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 as an IV infusion.

Drug: Itraconazole
Itraconazole will be administered orally.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]