Status:
COMPLETED
A Study to Investigate How Multiple Oral Doses of AZD2389 Affect the Pharmacokinetics of Midazolam, Caffeine, and Bupropion in Healthy Participants
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Advanced Chronic Liver Disease
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
This study is an open-label, fixed sequence, 3-period, drug-drug interaction (DDI) study in healthy participants performed at a single Clinical Unit. The study will comprise: * A Screening Period of...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06973005
Start Date
May 8 2025
End Date
July 18 2025
Last Update
July 24 2025
Active Locations (1)
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1
Research Site
Brooklyn, Maryland, United States, 21225