A Study to Investigate the Pharmacokinetics of AZD2389 in Healthy Participants When Administered Alone and in Combination With Quinidine

NCT06974565 | Completed Phase 1 FDA Drug

• 1 other identifier: D7930C00006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Chronic Liver Disease; Healthy Participants

Keywords

Hepatic Fibrosis; Fibroblast Activation Protein Inhibitor

Outcome Measures

Primary Outcomes (3)

• Ratio of Test treatment (AZD2389 + quinidine) to Reference treatment (AZD2389) based on maximum observed plasma concentration (RCmax)

  To assess the effect of quinidine on the PK of AZD2389.

  Day 1 to Day 10

• Ratio of Test treatment (AZD2389 + quinidine) to Reference treatment (AZD2389) based on area under concentration-time curve from time 0 to infinity (RAUCinf)

  To assess the effect of quinidine on the PK of AZD2389.

  Day 1 to Day 10

• Ratio of Test treatment (AZD2389 + quinidine) to Reference treatment (AZD2389) based on area under concentration-time curve from time 0 to the last quantifiable concentration (RAUClast)

  To assess the effect of quinidine on the PK of AZD2389.

  Day 1 to Day 10

Secondary Outcomes (12)

• Apparent total body clearance (CL/F) of AZD2389

  Day 1 to Day 10

• Volume of distribution (apparent) following extravascular administration (based on terminal phase) (Vz/F) of AZD2389

  Day 1 to Day 10

• Terminal elimination half-life (t1/2λz) of AZD2389

  Day 1 to Day 10

• Time to reach maximum observed concentration (tmax) of AZD2389

  Day 1 to Day 10

• Maximum observed plasma concentration (Cmax) of AZD2389

  Day 1 to Day 10

Study Arms (2)

Sequence AB

EXPERIMENTAL

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.

Drug: AZD2389; Drug: Quinidine

Sequence BA

EXPERIMENTAL

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.

Drug: AZD2389; Drug: Quinidine

Interventions

AZD2389 DRUG

AZD2389 will be administered orally.

Sequence AB; Sequence BA

Quinidine DRUG

Quinidine will be administered orally.

Sequence AB; Sequence BA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Brooklyn, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Quinidine

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cinchona Alkaloids; Alkaloids; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: May 12, 2025
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (1)