COMPLETED

A Study to Investigate How Multiple Oral Doses of AZD2389 Affect the Pharmacokinetics of Midazolam, Caffeine, and Bupropion in Healthy Participants

Conditions

Advanced Chronic Liver Disease Healthy Participants Hepatic Fibrosis FAP inhibitor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to measure the effect of multiple doses of AZD2389 on the pharmacokinetics (PK) of midazolam, caffeine, and bupropion in healthy participants.

Official Title

An Open-label, Fixed Sequence Study in Healthy Participants to Assess the Effect of Multiple Doses of AZD2389 on the Pharmacokinetics of Midazolam, Caffeine, and Bupropion

Quick Facts

Study Start:2025-05-08

Study Completion:2025-07-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06973005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Provision of signed and dated, written informed consent prior to any study-specific procedures. * Participants with suitable veins for cannulation or repeated venipuncture. * Have a body mass index (BMI) between 18 and 32 kilograms per meter squared (kg/m2) inclusive and weigh at least 50 kilograms (kg) at Screening.	* History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk. * 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. * Any clinically important abnormalities in clinical chemistry, coagulation, hematology, or urinalysis results. * Any positive result at the Screening Visit for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). * Abnormal vital signs, after 10 minutes supine rest, at the Screening Visit and/or admission to the Clinical Unit (Day -2). * Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead safety ECG. * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity. * History of hypersensitivity to DPP4 inhibitors, as judged by the investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to DPP4 inhibitors. * History of severe dermatological disorders, eg, bullous pemphigoid or Stevens-Johnson syndrome, as judged by the investigator. * Participants who have previously received AZD2389 within the last 12 months prior to the Screening Visit. * Known hypersensitivity or previous adverse events associated with midazolam, caffeine, or bupropion.

Inclusion Criteria

Exclusion Criteria

* Provision of signed and dated, written informed consent prior to any study-specific procedures.
* Participants with suitable veins for cannulation or repeated venipuncture.
* Have a body mass index (BMI) between 18 and 32 kilograms per meter squared (kg/m2) inclusive and weigh at least 50 kilograms (kg) at Screening.

* History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk.
* 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.
* Any clinically important abnormalities in clinical chemistry, coagulation, hematology, or urinalysis results.
* Any positive result at the Screening Visit for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
* Abnormal vital signs, after 10 minutes supine rest, at the Screening Visit and/or admission to the Clinical Unit (Day -2).
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead safety ECG.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
* History of hypersensitivity to DPP4 inhibitors, as judged by the investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to DPP4 inhibitors.
* History of severe dermatological disorders, eg, bullous pemphigoid or Stevens-Johnson syndrome, as judged by the investigator.
* Participants who have previously received AZD2389 within the last 12 months prior to the Screening Visit.
* Known hypersensitivity or previous adverse events associated with midazolam, caffeine, or bupropion.

Contacts and Locations

Study Locations (Sites)

Research Site

Brooklyn, Maryland, 21225

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-08

Study Completion Date2025-07-18

Study Record Updates

Study Start Date2025-05-08

Study Completion Date2025-07-18

Terms related to this study

Keywords Provided by Researchers

Hepatic Fibrosis
FAP inhibitor

Additional Relevant MeSH Terms

Advanced Chronic Liver Disease
Healthy Participants