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

NCT ID: NCT06846528

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-26
• Study Completion Date: 2025-04-23

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.

Conditions

Healthy Participants

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AZD2389 and Itraconazole

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.

Group Type: EXPERIMENTAL

AZD2389

Intervention Type: DRUG

AZD2389 is administered orally

Itraconazole

Intervention Type: DRUG

Itraconazole is administered orally

Interventions

AZD2389

AZD2389 is administered orally

Intervention Type: DRUG

Itraconazole

Itraconazole is administered orally

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Brooklyn, Maryland, United States

Countries

United States

Other Identifiers

D7930C00005

Identifier Type: -

Identifier Source: org_study_id