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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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