AZD2389 + Quinidine for Healthy Subjects

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: DPP4 inhibitors

Disqualifiers: Gastrointestinal, Hepatic, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

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. ^{1 2 3 4 5}

Why 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. ^{5 6 7 8 9}

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

I have tested negative for pregnancy before starting the trial.

I am a man who can father children and will use contraception during and for 3 months after the study.

I am a woman who cannot become pregnant, confirmed at my screening visit.

Exclusion Criteria

Positive screen for drugs of abuse, or alcohol or cotinine at Screening

I have smoked or used nicotine products within the last 3 months.

History of hypersensitivity to dipeptidyl peptidase 4 (DPP4) inhibitors

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment Period 1

Single dose administration of Treatment A (AZD2389) or Treatment B (AZD2389 + quinidine) on Day 1

1 day

1 visit (in-person)

Washout

Washout period between treatments

At least 7 days

Treatment Period 2

Single dose administration of the alternate treatment on Day 8

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 to 2 weeks

1 visit (in-person)

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?

Group I: Sequence BA Experimental Treatment 2 Interventions

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.

Group II: Sequence AB Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

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

Trials

322

Recruited

137,000+

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06846528

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 ...

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-1-2025-a2729

AZD2389 + Itraconazole for Healthy Subjects Itraconazole is a well-studied antifungal drug that has been shown to be effective in treating a wide range of fungal infections, including those affecting the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06974565?term=AREA%5BBasicSearch%5D(QUINIDINE)&rank=3

A 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 ...

4. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D7930C00001

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.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06750276

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 ...

6. selleckchem.com selleckchem.com/msds/azd2389-MSDS.html

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 ...

7. file.medchemexpress.com file.medchemexpress.com/batch_PDF/HY-172317/AZD2389-SDS-MedChemExpress.pdf

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 ...

8. dcchemicals.com dcchemicals.com/msds/MSDS_DC67420.html

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 ...

9. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D7930C00002

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.