NCT06974565

A Study to Investigate the Pharmacokinetics of AZD2389 in Healthy Participants When Administered Alone and in Combination With Quinidine

An Open-label, Randomized, Cross-over, Single Dose Study in Healthy Participants to Assess the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Quinidine

• 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 assess the pharmacokinetics (PK) and safety of AZD2389 when administered alone and in combination with quinidine in healthy participants.

Detailed description

This is a 2-way cross-over study to evaluate the effect of quinidine on the PK of AZD2389. The study will include 2 Treatments - Treatment A - AZD2389 Treatment B - AZD2389 + quinidine The study will comprise - 1. A Screening Period of maximum 28 days. 2. Period 1: single dose administration of Treatment A or Treatment B on Day 1. Period 2 will start after a washout period of at least 7 days. 3. Period 2: single dose of alternate treatment on Day 8. 4. A Follow-up Visit: participants will return for a Follow-up Visit, 7 to 14 days after the last AZD2389 PK sample in Period 2. Participants will be randomized to one of the 2 treatment sequences - 1. Sequence AB: Treatment A in Period 1, Treatment B in Period 2. 2. Sequence BA: Treatment B in Period 1, Treatment A in Period 2.

Conditions

• Advanced Chronic Liver Disease
• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD2389	AZD2389 will be administered orally.
DRUG	Quinidine	Quinidine will be administered orally.

Timeline

• Start date: 2025-05-12
• Primary completion: 2025-07-18
• Completion: 2025-07-18
• First posted: 2025-05-16
• Last updated: 2025-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study