A Phase 1 interventional study of AZD4144 and AZD4144 in Healthy, sponsored by AstraZeneca. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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:
AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
AZD4144 will be administered orally.
AZD4144 will be administered as an IV infusion.
Itraconazole will be administered orally.
Area under concentration time curve from time 0 to infinity (AUCinf)
To assess the effect of itraconazole on the PK (AUCinf) of AZD4144
Time frame: 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
Time frame: 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
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Total body clearance (CL)
To describe the PK (CL) of AZD4144 when administered alone, and in combination with itraconazole
Time frame: 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
Time frame: 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
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)
To describe the PK (Vz/F) of AZD4144 when administered alone, and in combination with itraconazole
Time frame: 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
Time frame: 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
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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