A Study to Investigate How Multiple Oral Doses of AZD2389 Affect the Pharmacokinetics of Midazolam, Caffeine, and Bupropion in Healthy Participants
Completed · Phase 1
Conditions studied: Advanced Chronic Liver Disease, Healthy Participants
In brief
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.
Key facts
- Study ID
- NCT06973005
- Run by
- AstraZeneca
- People needed
- 16
- Starts
- 2025-05-08
- Expected to finish
- 2025-07-18
- Last updated by the study team
- 2025-07-24
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Research Site — Brooklyn, Maryland, United States
Full record on ClinicalTrials.gov
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