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Completed

NCT Number: NCT06138795

A Single and Multiple Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 in Healthy Participants

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD2389 following single and multiple dose administration (SAD/MAD) to healthy participants.

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Key information

Conditions

Healthy Participants Digestive System Diseases Liver Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Glendale, California, 91206, United States

About this study

This is a Phase I, First In Human (FIH), randomized, single-blind, placebo-controlled, single and multiple ascending dose study in healthy male and/or female participants of non-childbearing potential including healthy participants of Chinese and Japanese ethnicity performed at a single center.

The study consists of 2 parts: Part A and Part B. Part A has been planned to be conducted with 78 participants and Part B has been planned to be conducted with 32 participants.

Each participant in Part A and Part B will be involved in the study for up to 8 weeks.

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.
  • For the healthy Japanese cohorts (Parts A2 and B2): healthy participants are to be Japanese (e.g., natives of Japan or Japanese Americans), defined as having both parents and 4 grandparents who are Japanese. This includes healthy second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
  • For the healthy Chinese cohort (Part A3): healthy participants are to be Chinese defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.

Exclusion criteria

  • Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
  • Known or suspected history of alcohol or drug abuse and smokers.
  • Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
  • History of coagulation or bleeding disorders or use of anti-platelets/anti-coagulants during the 3 months prior to the Screening Visit, as judged by the investigator.
  • History of hypersensitivity as judged by the investigator, to drugs with a similar chemical structure or class.
  • History of severe dermatological disorders, eg, bullous pemphigoid or Stevens-Johnson syndrome, or clinically significant new or healing wounds in areas of the body not always covered by clothing such as face, forearm, and lower leg, as judged by the investigator.

Treatment and study plan

AZD2389

Drug

Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose.

Placebo

Drug

Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose.

Primary outcomes

  1. Part A (SAD): Number of participants with adverse events (AE) and serious adverse events (SAE)

    Time frame: Day ≤ -28 (Only SAE), Day -1 (Only SAE), Days 1 and 2, Day 8 Post-dose (± 1 day)

    To assess the safety and tolerability of AZD2389 following oral administration of single ascending doses in healthy participants, including Japanese and Chinese participants.

  2. Part B (MAD): Number of participants with AE and SAE

    Time frame: Day ≤ -28 (Only SAE), Day -1 (Only SAE), Days 1 to 12, Day 17 (± 1 day)

    To assess the safety and tolerability of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

Secondary outcomes

  1. Part A (SAD): Plasma concentrations of AZD2389

    Time frame: Day 1 and Day 2

    To characterize the plasma concentration of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  2. Part A (SAD): Urine concentrations of AZD2389

    Time frame: Day 1 and Day 2

    To characterize the urine concentration of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  3. Part A (SAD): Terminal rate constant (λz)

    Time frame: Day 1 and Day 2

    To characterize the λz of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  4. Part A (SAD): Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)]

    Time frame: Day 1 and Day 2

    To characterize the Ae(t1-t2) of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  5. Part A (SAD): Area under plasma concentration time curve from zero to infinity (AUCinf)

    Time frame: Day 1 and Day 2

    To characterize the AUCinf of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  6. Part A (SAD): Dose normalized AUCinf (AUCinf/D)

    Time frame: Day 1 and Day 2

    To characterize the AUCinf/D of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  7. Part A (SAD): Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)

    Time frame: Day 1 and Day 2

    To characterize the AUClast of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  8. Part A (SAD): Dose normalized AUClast (AUClast/D)

    Time frame: Day 1 and Day 2

    To characterize the AUClast/D of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  9. Part A (SAD): Apparent total body clearance of drug (CL/F)

    Time frame: Day 1 and Day 2

    To characterize the CL/F of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  10. Part A (SAD): Maximum observed plasma (peak) drug concentration (Cmax)

    Time frame: Day 1 and Day 2

    To characterize the Cmax of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  11. Part A (SAD): Dose normalized Cmax (Cmax/D)

    Time frame: Day 1 and Day 2

    To characterize the Cmax/D of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  12. Part A (SAD): Renal clearance (CLR)

    Time frame: Day 1 and Day 2

    To characterize the CLR of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  13. Part A (SAD): Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 [fe(t1-t2)]

    Time frame: Day 1 and Day 2

    To characterize the fe(t1-t2) of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  14. Part A (SAD): Mean residence time (MRTinf)

    Time frame: Day 1 and Day 2

    To characterize the MRTinf of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  15. Part A (SAD): Apparent terminal elimination half-life (t½λz)

    Time frame: Day 1 and Day 2

    To characterize the t½λz of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  16. Part A (SAD): Time of last quantifiable concentration (tlast)

    Time frame: Day 1 and Day 2

    To characterize the tlast of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  17. Part A (SAD): Time to reach peak or maximum observed concentration (tmax)

    Time frame: Day 1 and Day 2

    To characterize the tmax of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  18. Part A (SAD): Apparent volume of distribution based on the terminal phase (Vz/F)

    Time frame: Day 1 and Day 2

    To characterize the Vz/F of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  19. Part A (SAD): Change in PD biomarkers over time

    Time frame: Day 1 and Day 2

    To characterize the percentage change in PD biomarkers over time compared to baseline of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.

  20. Part B (MAD): Plasma concentrations of AZD2389

    Time frame: Day 1 to Day 12

    To characterize the plasma concentration of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  21. Part B (MAD): Urine concentrations of AZD2389

    Time frame: Day 1 and Days 10 to 12

    To characterize the urine concentration of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  22. Part B (MAD): Terminal rate constant (λz)

    Time frame: Day 1 to Day 12

    To characterize the λz of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  23. Part B (MAD): Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)]

    Time frame: Day 1 and Days 10 to 12

    To characterize the Ae(t1-t2) of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  24. Part B (MAD): Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)

    Time frame: Day 1 to Day 12

    To characterize the AUClast of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  25. Part B (MAD): Area under the concentration-time curve in the dose interval (AUCtau)

    Time frame: Day 1 to Day 12

    To characterize the AUCtau of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  26. Part B (MAD): Dose normalized AUCtau (AUCtau/D)

    Time frame: Day 1 to Day 12

    To characterize the AUCtau/D of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  27. Part B (MAD): Dose normalized AUClast (AUClast/D)

    Time frame: Day 1 to Day 12

    To characterize the AUClast/D of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  28. Part B (MAD): Apparent total body clearance of drug (CL/F)

    Time frame: Day 1 and Days 10 to 12

    To characterize the CL/F of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  29. Part B (MAD): Renal clearance (CLR)

    Time frame: Day 1 and Days 10 to 12

    To characterize the CLR of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  30. Part B (MAD): Maximum observed plasma (peak) drug concentration (Cmax)

    Time frame: Day 1 to Day 12

    To characterize the Cmax of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  31. Part B (MAD): Dose normalized Cmax (Cmax/D)

    Time frame: Day 1 to Day 12

    To characterize the Cmax/D of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  32. Part B (MAD): Observed lowest concentration before the next dose is administered(Ctrough)

    Time frame: Day 1 to Day 12

    To characterize the Ctrough of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  33. Part B (MAD): Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 [fe(t1-t2)]

    Time frame: Day 1 and Days 10 to 12

    To characterize the fe(t1-t2) of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  34. Part B (MAD): Accumulation ratio for AUC (Rac AUC)

    Time frame: Day 1 to Day 12

    To characterize the Rac AUC of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  35. Part B (MAD): Accumulation ratio for Cmax (Rac Cmax)

    Time frame: Day 1 to Day 12

    To characterize the Rac Cmax of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  36. Part B (MAD): Time to reach peak or maximum observed concentration (tmax)

    Time frame: Day 1 to Day 12

    To characterize the tmax of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  37. Part B (MAD): Apparent terminal elimination half-life (t½λz)

    Time frame: Day 1 to Day 12

    To characterize the t½λz of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  38. Part B (MAD): Apparent volume of distribution based on the terminal phase (Vz/F)

    Time frame: Day 1 to Day 12

    To characterize the Vz/F of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

  39. Part B (MAD): Change in PD biomarkers over time

    Time frame: Days 1, 2, 4, 8, and 10

    To characterize the percentage change in PD biomarkers over time compared to baseline of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 After Single and Multiple Ascending Doses to Healthy Participants.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Sep 9, 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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