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

AstraZeneca16 enrolled

Overview

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: * 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

AZD2389DRUG

AZD2389 is administered orally

ItraconazoleDRUG

Itraconazole is administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Brooklyn, Maryland, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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