A Study to Investigate the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole in Healthy Participants

NCT06846528 | Completed Phase 1 FDA Drug

• 1 other identifier: D7930C00005
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

Fibroblast Activation Protein inhibitor; Advanced hepatic fibrosis; Chronic liver disease

Outcome Measures

Primary Outcomes (3)

• Maximum observed drug concentration (Cmax) of AZD2389

  To assess the effect of itraconazole on the Cmax of AZD2389.

  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.

  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.

  Day 1 to Day 8

Secondary Outcomes (12)

• Apparent total body clearance (CL/F) of AZD2389

  Day 1 to Day 8

• Apparent volume of distribution based on the terminal phase (Vz/F) of AZD2389

  Day 1 to Day 8

• Terminal elimination half-life (t1/2λz) of AZD2389

  Day 1 to Day 8

• Time to reach maximum observed concentration (tmax) of AZD2389

  Day 1 to Day 8

• Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on Cmax (RCmax) of AZD2389

  Day 1 to Day 8

Study Arms (1)

AZD2389 and Itraconazole

EXPERIMENTAL

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

Interventions

AZD2389 DRUG

AZD2389 is administered orally

AZD2389 and Itraconazole

Itraconazole DRUG

Itraconazole is administered orally

AZD2389 and Itraconazole

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Brooklyn, Maryland, 21225, United States

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: February 26, 2025
• Primary Completion: April 23, 2025
• Study Completion: April 23, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

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 refer 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 environmentVivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (1)