Investigating how AZD2389 behaves in the body alone and with quinidine

An Open-label, Randomized, Cross-over, Single Dose Study in Healthy Participants to Assess the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Quinidine

This study is testing how the drug AZD2389 works in the body by itself and with another drug called quinidine in healthy volunteers.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 1 site (Brooklyn, Maryland)
• Trial ID: NCT06974565 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the pharmacokinetics and safety of AZD2389, both alone and in combination with quinidine, in healthy participants. It employs a 2-way cross-over design where participants will receive each treatment after a washout period. The study includes a screening phase, followed by two treatment periods, and concludes with a follow-up visit to assess the effects of the drug combinations. Participants will be randomized to receive the treatments in different sequences to ensure comprehensive data collection.

Who should consider this trial

Good fit: Ideal candidates are healthy male and female participants of non-childbearing potential, aged 18-65, with a suitable body mass index and no significant health issues.

Not a fit: Patients with a history of gastrointestinal, hepatic, or renal diseases, or any condition affecting drug metabolism will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the safe administration of AZD2389, potentially improving treatment strategies for conditions like advanced chronic liver disease.

How similar studies have performed: While this specific combination has not been extensively tested, similar pharmacokinetic studies have shown promising results in understanding drug interactions.

Eligibility criteria

Inclusion Criteria:

* Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture.
* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
* Females of non-childbearing potential must be confirmed at the Screening Visit.
* Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods from the time of first administration of study intervention administration until 3 months after the study Follow-up Visit.
* Have a body mass index between 18 and 32 kg/m2, inclusive, and weigh at least 50 kg at the Screening Visit.

Exclusion Criteria:

* History of any clinically important disease or disorder.
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important abnormalities in hematology, clinical chemistry, urinalysis, coagulation results or other laboratory values and vital signs.
* Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV).
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG) at Screening.
* Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
* Current smokers or those who have smoked or used nicotine products within the previous 3 months prior to screening.
* Positive screen for drugs of abuse, or alcohol or cotinine at Screening.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
* History of hypersensitivity to dipeptidyl peptidase 4 (DPP4) inhibitors.

Where this trial is running

Brooklyn, Maryland

• Research Site — Brooklyn, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Advanced Chronic Liver Disease; Healthy Participants; Hepatic Fibrosis; Fibroblast Activation Protein Inhibitor