AZD2389 for Drug Processing in Healthy Subjects

(CRIOLLO Trial)

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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the new treatment, AZD2389, affects the body's processing of common substances like midazolam, caffeine, and bupropion. Participants will receive these substances both with and without AZD2389 to determine if the treatment alters drug absorption and breakdown. The trial seeks healthy participants without recent major illnesses or known allergies to these substances. As a Phase 1 trial, this research focuses on understanding AZD2389's effects in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that AZD2389 is likely to be safe for humans?

Research has shown that AZD2389 has undergone testing in several studies to assess its safety for people. These studies examined how the body processes the drug and identified any side effects. Results suggest that AZD2389 is generally well-tolerated by healthy participants.

In one study, researchers tested the drug both alone and with another medication, itraconazole, and found it to be safe. Another study compared AZD2389 to a placebo and also found it to be well-tolerated.

These results are encouraging, but it's important to remember that this is early-stage research. While AZD2389 appears safe, further research is needed to confirm these findings in a larger group of people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AZD2389 because it offers a novel approach to drug metabolism in the body. Unlike traditional treatments which often focus on a single medication, AZD2389 is being studied for its ability to interact with multiple drugs such as midazolam, caffeine, and bupropion, potentially optimizing how they are processed together. This could lead to more effective and safer medication regimens by ensuring medications are metabolized correctly when used in combination.

What evidence suggests that AZD2389 might be effective for drug processing?

Research shows that AZD2389 is under study to determine its impact on how the body processes other drugs. Animal studies have demonstrated positive effects on metabolism-related health. This trial will examine AZD2389's interactions with drugs such as midazolam, caffeine, and bupropion, which are commonly used to study drug metabolism. Although research in humans continues, AZD2389 is being carefully evaluated for its potential effects on these processes. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Healthy adults with a BMI of 18-32 kg/m2 and weighing at least 50 kg can join. They must have good veins for drawing blood, give written consent, and not have any serious health issues or allergies that could affect the study. People with abnormal vital signs, severe skin conditions, recent illnesses or procedures, liver disease, positive tests for hepatitis B/C or HIV cannot participate.

Inclusion Criteria

I have veins suitable for repeated needle insertions.

Provision of signed and dated, written informed consent prior to any study-specific procedures

My BMI is between 18 and 32, and I weigh at least 50 kg.

Exclusion Criteria

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

History of severe dermatological disorders, eg, bullous pemphigoid or Stevens-Johnson syndrome, as judged by the investigator

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment Period 1

Participants receive midazolam and caffeine on Day 1, and bupropion on Day 2

4 days

Treatment Period 2

Participants receive AZD2389 for 9 days

9 days

Treatment Period 3

Participants receive AZD2389 with midazolam and caffeine on Day 14, AZD2389 with bupropion on Day 15, and AZD2389 alone on Days 16 and 17

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AZD2389

Trial Overview The trial is testing how taking multiple doses of AZD2389 affects the body's handling of midazolam (a sedative), caffeine (a stimulant), and bupropion (an antidepressant). Researchers want to see if AZD2389 changes how these drugs are absorbed and processed by healthy individuals.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 4 Interventions

In Period 1, participants will receive midazolam and caffeine in combination on Day 1. Participants will receive bupropion on Day 2. In Period 2, participants will receive AZD2389 for 9 days from Day 5 to Day 13. In Period 3, 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.

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 participants ...

2. 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 ...

3. 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 ...

4. 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.

5. drughunter.com drughunter.com/molecule/azd2389

AstraZeneca Discloses AZD2389, a Reversible Covalent ... AZD2389's ADME-PK and safety profiles supported a detailed 29-week study of MASH in NHPs, which showed positive effects. The compound has now ...

6. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-10-2023-09fba

AZD2389 Safety and Pharmacokinetics in Healthy Subjects This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD2389 following single and multiple dose administration ( ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06812780

NCT06812780 | A Study to Investigate the Effect of Hepatic ... The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic ...