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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: AZD2389

Drug: Itraconazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT06846528

D7930C00005

Details and patient eligibility

About

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

Full 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.

Enrollment

16 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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