Clinical trial NCT06846528: A Study to Investigate the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole in Healthy Participants
Official title: An Open-label, Fixed Sequence Study in Healthy Participants to Assess the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Fibroblast Activation Protein inhibitor
Advanced hepatic fibrosis
Chronic liver disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2025-02-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the pharmacokinetics (PK) of AZD2389 when administered alone and in combination with itraconazole in healthy participants.

Detailed description: This study will be an open-label, fixed sequence, Drug-Drug Interaction (DDI) study consisting of 3 periods.

The study will comprise:

* A screening period of maximum 28 days
* Period 1
* Period 2
* Period 3
* A Follow-up Visit 7 to 14 days after the last PK sample has been collected.

Eligibility criteria: Inclusion Criteria:

* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
* Females of non-childbearing potential must be postmenopausal for at least 12 months or have documentation of irreversible surgical sterilization.
* Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
* Have a Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg.

Exclusion Criteria:

* History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
* Abnormal laboratory values, clinically important abnormalities or abnormal vital signs
* Any positive result on screening for serum Hepatitis B surface antigen/antibody, Hepatitis C, or Human Immunodeficiency Virus.
* Current smokers (within 3 months prior to screening visit) or history of alcohol and drug abuse
* History of severe allergy or hypersensitivity
* Excessive intake of caffeine-containing drinks or food
* Use of drugs with enzyme inducing properties or use of any prescribed or nonprescribed medication including antacids, analgesics

Primary outcomes:
measure: Maximum observed drug concentration (Cmax) of AZD2389
timeFrame: Day 1 to Day 8
measure: Area under concentration-timecurve from time zero to infinity (AUCinf) of AZD2389
timeFrame: Day 1 to Day 8
measure: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD2389
timeFrame: Day 1 to Day 8
Secondary outcomes:
measure: Apparent total body clearance (CL/F) of AZD2389
timeFrame: Day 1 to Day 8
measure: Apparent volume of distribution based on the terminal phase (Vz/F) of AZD2389
timeFrame: Day 1 to Day 8
measure: Terminal elimination half-life (t1/2λz) of AZD2389
timeFrame: Day 1 to Day 8
measure: Time to reach maximum observed concentration (tmax) of AZD2389
timeFrame: Day 1 to Day 8
measure: Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on Cmax (RCmax) of AZD2389
timeFrame: Day 1 to Day 8
measure: Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on AUClast (RAUClast) of AZD2389
timeFrame: Day 1 to Day 8
measure: Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on AUCinf (RAUCinf) of AZD2389
timeFrame: Day 1 to Day 8
measure: Renal Clearance (CLR) of AZD2389
timeFrame: Day 1 to Day 8
measure: Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 (Ae(t1-t2)) of AZD2389
timeFrame: Day 1 to Day 8
measure: Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 (fe(t1-t2)) of AZD2389
timeFrame: Day 1 to Day 8
measure: Percent change from baseline in fibroblast activation protein (FAP) inhibition
timeFrame: Day 1 to Day 8
measure: Number of participants with Adverse Events (AEs)
timeFrame: From Screening (Day -29 to Day -2) up to 8 weeks
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Research Site
state: Maryland
Study officials:
References: