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

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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