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Completed

NCT Number: NCT06846528

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

The purpose of this study is to assess the pharmacokinetics (PK) of AZD2389 when administered alone and in combination with itraconazole 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 study will be an open-label, fixed sequence, Drug-Drug Interaction (DDI) study consisting of 3 periods.

The study will comprise:

  • A screening period of maximum 28 days
  • Period 1
  • Period 2
  • Period 3
  • A Follow-up Visit 7 to 14 days after the last PK sample has been collected.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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 postmenopausal for at least 12 months or have documentation of irreversible surgical sterilization.
  • Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
  • Have a Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg.

Exclusion criteria

  • History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
  • 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 illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
  • Abnormal laboratory values, clinically important abnormalities or abnormal vital signs
  • Any positive result on screening for serum Hepatitis B surface antigen/antibody, Hepatitis C, or Human Immunodeficiency Virus.
  • Current smokers (within 3 months prior to screening visit) or history of alcohol and drug abuse
  • History of severe allergy or hypersensitivity
  • Excessive intake of caffeine-containing drinks or food
  • Use of drugs with enzyme inducing properties or use of any prescribed or nonprescribed medication including antacids, analgesics

Treatment and study plan

AZD2389

Drug

AZD2389 is administered orally

Itraconazole

Drug

Itraconazole is administered orally

Primary outcomes

  1. Maximum observed drug concentration (Cmax) of AZD2389

    Time frame: Day 1 to Day 8

    To assess the effect of itraconazole on the Cmax of AZD2389.

  2. Area under concentration-timecurve from time zero to infinity (AUCinf) of AZD2389

    Time frame: Day 1 to Day 8

    To assess the effect of itraconazole on the AUCinf of AZD2389.

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

    Time frame: Day 1 to Day 8

    To assess the effect of itraconazole on the AUClast of AZD2389.

Secondary outcomes

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

    Time frame: Day 1 to Day 8

    To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole

  2. Apparent volume of distribution based on the terminal phase (Vz/F) of AZD2389

    Time frame: Day 1 to Day 8

    To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole

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

    Time frame: Day 1 to Day 8

    To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.

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

    Time frame: Day 1 to Day 8

    To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.

  5. Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on Cmax (RCmax) of AZD2389

    Time frame: Day 1 to Day 8

    To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.

  6. Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on AUClast (RAUClast) of AZD2389

    Time frame: Day 1 to Day 8

    To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.

  7. Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on AUCinf (RAUCinf) of AZD2389

    Time frame: Day 1 to Day 8

    To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.

  8. Renal Clearance (CLR) of AZD2389

    Time frame: Day 1 to Day 8

    To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.

  9. 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 8

    To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.

  10. 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 8

    To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.

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

    Time frame: Day 1 to Day 8

    To evaluate 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 itraconazole.

  12. Number of participants with Adverse Events (AEs)

    Time frame: From Screening (Day -29 to Day -2) up to 8 weeks

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Parexel

Registry information

Official study title

An Open-label, Fixed Sequence Study in Healthy Participants to Assess the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2025
Registry last updated
Apr 29, 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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