NCT06973005

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Advanced Chronic Liver Disease
• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD2389	Oral dose on Days 5 to 13, Day 16, and Day 17. On Day 14 co-administered with a combination of midazolam and caffeine. On Day 15 co-administered with bupropion.
DRUG	Midazolam	Single oral dose on: * Day 1 (co-administered with caffeine) * Day 14 (co-administered with caffeine and AZD2389)
DRUG	Caffeine	Single oral dose on: * Day 1 (co-administered with midazolam) * Day 14 (co-administered with midazolam and AZD2389)
DRUG	Bupropion	Single oral dose on: * Day 2 (alone) * Day 15 (co-administered with AZD2389)

Timeline

• Start date: 2025-05-08
• Primary completion: 2025-07-18
• Completion: 2025-07-18
• First posted: 2025-05-15
• Last updated: 2025-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study