AZD2389 + Quinidine for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on how the body processes and responds to a new treatment, AZD2389, both alone and in combination with quinidine (a medication for certain irregular heartbeats). The main goal is to assess the safety and pharmacokinetics of the drug in healthy individuals. Participants will receive doses in varying sequences to determine any differences in drug interaction. Individuals who are generally healthy, with no significant disease or allergy history, and who have not recently smoked or used nicotine, may be suitable for this study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study tested AZD2389 to assess its safety when used alone. The results showed it was generally well-tolerated by healthy individuals. However, AZD2389 can be dangerous if swallowed and harmful to aquatic life.
Another study examined AZD2389 combined with quinidine, focusing on the body's processing of these drugs and their safety. The study confirmed that the combination was generally safe for healthy participants.
Since this trial is in the early stages, it primarily focuses on how the body processes the drug and its safety. This phase usually involves fewer participants to closely monitor any side effects or reactions.12345Why are researchers excited about this trial's treatments?
Researchers are excited about AZD2389, especially when paired with quinidine, because it offers a fresh approach to managing conditions related to the cardiovascular system. Unlike traditional treatments that focus on symptom management, AZD2389 works by potentially modulating specific pathways that influence heart rhythm. Quinidine is often used to enhance the effects of other drugs, and when combined with AZD2389, it may amplify its benefits, offering a novel therapeutic angle. This combination could lead to improved outcomes and more targeted interventions compared to existing options like beta-blockers or calcium channel blockers.
What evidence suggests that this trial's treatments could be effective?
Research has shown that AZD2389 is under study to assess its safety and how the body processes it. No direct evidence yet confirms its effectiveness for any specific health issue. In this trial, participants will receive AZD2389 alone in one period and AZD2389 combined with quinidine in another to study their interaction. Quinidine treats heart rhythm problems, but its interaction with AZD2389 remains unknown. Early studies are evaluating the safety of using these drugs together, but no clear results yet indicate their effectiveness for any condition.56789
Are You a Good Fit for This Trial?
This trial is for healthy individuals who can help understand how the body processes a new drug, AZD2389, both alone and when taken with another medication called Quinidine. Specific details about eligibility are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Single dose administration of Treatment A (AZD2389) or Treatment B (AZD2389 + quinidine) on Day 1
Washout
Washout period between treatments
Treatment Period 2
Single dose administration of the alternate treatment on Day 8
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD2389
- Quinidine
Trial Overview
Researchers are studying how AZD2389 behaves in the body (its pharmacokinetics) when given by itself and alongside Quinidine to see if there's any interaction between them. The safety of this combination will also be evaluated.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive a single dose of Treatment B (AZD2389 + quinidine) in Period 1 and a single dose of Treatment A (AZD2389) in Period 2.
Participants will receive a single dose of Treatment A (AZD2389) in Period 1 and a single dose of Treatment B (AZD2389 + quinidine) in Period 2.
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Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Parexel
Industry Sponsor
Peyton Howell
Parexel
Chief Executive Officer
Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois
Dr. Austin Smith
Parexel
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland
Citations
A Study to Investigate the Pharmacokinetics of AZD2389 ...
The purpose of this study is to assess the pharmacokinetics (PK) of AZD2389 when administered alone and in combination with itraconazole in healthy ...
AZD2389 + Itraconazole for Healthy Subjects
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3.
clinicaltrials.gov
clinicaltrials.gov/study/NCT06974565?term=AREA%5BBasicSearch%5D(QUINIDINE)&rank=3A Study to Investigate the Pharmacokinetics of AZD2389 in ...
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 ...
A single and multiple ascending dose study to investigate ...
A single and multiple ascending dose study to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD2389 in healthy participants.
NCT06750276 | A Study to Evaluate the Safety, Tolerability ...
The purpose of this study is to measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 as compared to placebo ...
AZD2389 | Safety Data Sheet
Toxic. Contains a pharmaceutically active ingredient. Handling should only be performed by personnel trained and familiar with handling of potent active ...
Safety Data Sheet
AZD2389. Catalog No. : HY-172317. CAS No. : 2791472-12-1. 1.2 Relevant identified uses of the substance or mixture and uses advised against. Identified uses ...
AZD2389|2791472-12-1|MSDS
2. HAZARDS IDENTIFICATION ; H302. Harmful if swallowed. ; H410. Very toxic to aquatic life with long lasting effects. ; P264. Wash skin thoroughly ...
A study to evaluate the safety, tolerability, PK, and PD ...
The purpose of this study is to measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 as compared to placebo.
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