A Phase 1 interventional study of AZD2389 and Itraconazole in Healthy Participants, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the pharmacokinetics (PK) of AZD2389 when administered alone and in combination with itraconazole in healthy participants.
This study will be an open-label, fixed sequence, Drug-Drug Interaction (DDI) study consisting of 3 periods.
The study will comprise:
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:
AZD2389 is dosed on days 1 and 6. Itraconazole is dosed on days 3,4,5,6,7, with the dose on day 6 coming after AZD2389.
Drug: AZD2389 · Drug: Itraconazole
AZD2389 is administered orally
Itraconazole is administered orally
Maximum observed drug concentration (Cmax) of AZD2389
To assess the effect of itraconazole on the Cmax of AZD2389.
Time frame: Day 1 to Day 8
Area under concentration-timecurve from time zero to infinity (AUCinf) of AZD2389
To assess the effect of itraconazole on the AUCinf of AZD2389.
Time frame: Day 1 to Day 8
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD2389
To assess the effect of itraconazole on the AUClast of AZD2389.
Time frame: Day 1 to Day 8
Apparent total body clearance (CL/F) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole
Time frame: Day 1 to Day 8
Apparent volume of distribution based on the terminal phase (Vz/F) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole
Time frame: Day 1 to Day 8
Terminal elimination half-life (t1/2λz) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
Time to reach maximum observed concentration (tmax) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on Cmax (RCmax) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on AUClast (RAUClast) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on AUCinf (RAUCinf) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
Renal Clearance (CLR) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 (Ae(t1-t2)) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 (fe(t1-t2)) of AZD2389
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
Percent change from baseline in fibroblast activation protein (FAP) inhibition
To evaluate the pharmacodynamics (PD) of AZD2389 by assessment of inhibition of FAP activity in plasma after single oral dose of AZD2389 alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
Number of participants with Adverse Events (AEs)
To assess the safety and tolerability of a single oral dose of AZD2389 alone or in combination with itraconazole in healthy participants.
Time frame: From Screening (Day -29 to Day -2) up to 8 weeks
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 approved.
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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