Investigating the effects of AZD2389 on drug metabolism in healthy individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate how multiple doses of AZD2389 influence the pharmacokinetics of midazolam, caffeine, and bupropion in healthy participants. It is designed as an open-label, fixed sequence, three-period drug-drug interaction study conducted at a single clinical unit. Participants will undergo a screening period followed by a treatment phase consisting of three distinct periods, where they will receive the drugs in various combinations over a specified timeline. The study will conclude with a follow-up visit to assess the pharmacokinetics after the last dose of AZD2389.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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.

Where it's running

• Research Site
  Brooklyn, Maryland, United States Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.