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

Last updated: May 16, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1

Condition

Primary Biliary Cholangitis

Treatment

AZD2389

Midazolam

Bupropion

Clinical Study ID

NCT06973005
D7930C00007
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provision of signed and dated, written informed consent prior to any study-specificprocedures.

  • 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

Exclusion Criteria:

  • History of any clinically important disease or disorder which, in the opinion of theinvestigator, may either put the participant at risk.

  • History or presence of gastrointestinal, hepatic, or renal disease or any othercondition known to interfere with absorption, distribution, metabolism, or excretionof drugs.

  • Any clinically important illness, medical/surgical procedure, or trauma within 4weeks 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 humanimmunodeficiency virus (HIV).

  • Abnormal vital signs, after 10 minutes supine rest, at the Screening Visit and/oradmission to the Clinical Unit (Day -2).

  • Any clinically important abnormalities in rhythm, conduction, or morphology of theresting 12-lead safety ECG.

  • History of severe allergy/hypersensitivity or ongoing clinically importantallergy/hypersensitivity.

  • History of hypersensitivity to DPP4 inhibitors, as judged by the investigator, orhistory of hypersensitivity to drugs with a similar chemical structure or class toDPP4 inhibitors.

  • History of severe dermatological disorders, eg, bullous pemphigoid orStevens-Johnson syndrome, as judged by the investigator.

  • Participants who have previously received AZD2389 within the last 12 months prior tothe Screening Visit.

  • Known hypersensitivity or previous adverse events associated with midazolam,caffeine, or bupropion.

Study Design

Total Participants: 16
Treatment Group(s): 4
Primary Treatment: AZD2389
Phase: 1
Study Start date:
May 08, 2025
Estimated Completion Date:
July 04, 2025

Study 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 maximum 28 days.

  • A Treatment Phase, separated into 3 different periods. Period 1 (Day -2 to Day 4): Participants will receive midazolam and caffeine in combination on Day 1. Participants will receive bupropion on Day 2.

Period 2 (Day 5 to Day 13): Participants will receive AZD2389 for 9 days. Period 3 (Day 14 to Day 18): Participants will first receive AZD2389 with midazolam and caffeine in combination on Day 14. On Day 15, participants will first receive AZD2389 with bupropion. On Days 16 and 17, participants will receive AZD2389.

  • A final Follow-up Visit, 7 to 14 days after the last AZD2389 PK sample is taken in Period 3.

Connect with a study center

  • Research Site

    Brooklyn, Maryland 21225
    United States

    Active - Recruiting

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