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Completed

NCT Number: NCT06974565

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Brooklyn, Maryland, 21225, United States

About this study

This is a 2-way cross-over study to evaluate the effect of quinidine on the PK of AZD2389.

The study will include 2 Treatments - Treatment A - AZD2389 Treatment B - AZD2389 + quinidine

The study will comprise -

  • A Screening Period of maximum 28 days.
  • Period 1: single dose administration of Treatment A or Treatment B on Day 1. Period 2 will start after a washout period of at least 7 days.
  • Period 2: single dose of alternate treatment on Day 8.
  • A Follow-up Visit: participants will return for a Follow-up Visit, 7 to 14 days after the last AZD2389 PK sample in Period 2.

Participants will be randomized to one of the 2 treatment sequences -

  • Sequence AB: Treatment A in Period 1, Treatment B in Period 2.
  • Sequence BA: Treatment B in Period 1, Treatment A in Period 2.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD2389

Drug

AZD2389 will be administered orally.

Quinidine

Drug

Quinidine will be administered orally.

Primary outcomes

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

    Time frame: Day 1 to Day 10

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

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

    Time frame: Day 1 to Day 10

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

  3. 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)

    Time frame: Day 1 to Day 10

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

Secondary outcomes

  1. Apparent total body clearance (CL/F) of AZD2389

    Time frame: Day 1 to Day 10

    To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.

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

    Time frame: Day 1 to Day 10

    To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.

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

    Time frame: Day 1 to Day 10

    To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.

  4. Time to reach maximum observed concentration (tmax) of AZD2389

    Time frame: Day 1 to Day 10

    To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.

  5. Maximum observed plasma concentration (Cmax) of AZD2389

    Time frame: Day 1 to Day 10

    To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.

  6. Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD2389

    Time frame: Day 1 to Day 10

    To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.

  7. Area under concentration-time curve from time zero to infinity (AUCinf) of AZD2389

    Time frame: Day 1 to Day 10

    To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.

  8. Renal Clearance (CLR) of AZD2389 from plasma

    Time frame: Day 1 to Day 10

    To assess the urine PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.

  9. Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 (fe[t1-t2]) of AZD2389

    Time frame: Day 1 to Day 10

    To assess the urine PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.

  10. Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 (Ae[t1-t2]) of AZD2389

    Time frame: Day 1 to Day 10

    To assess the urine PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.

  11. Percent change from baseline in fibroblast activation protein (FAP) inhibition

    Time frame: Baseline, Day 1 to Day 10

    To assess the pharmacodynamics (PD) of AZD2389 by assessment of inhibition of FAP activity in plasma after single oral dose of AZD2389 alone or in combination with quinidine.

  12. Number of participants with Adverse Events (AEs)

    Time frame: From Screening (Day -28 to Day -2) to Follow-up visit (upto 8 weeks)

    To assess the safety and tolerability of a single oral dose of AZD2389 alone or in combination with quinidine in healthy participants.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Parexel

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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