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NCT Number: NCT07290283

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD3974 in Healthy Participants

The purpose of this study is to assess the safety and tolerability of AZD3974 and characterize the pharmacokinetics (PK) of AZD3974 following oral administration to healthy participants, including participants of Japanese and Chinese descent.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Glendale, California, United States

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About this study

This is a first in human, randomized, single-blind, placebo-controlled study. It consists of two parts.

Part A (single ascending dose - SAD): This study part will enroll six cohorts (plus two optional additional cohorts) of healthy participants (Part A1), three cohorts (plus one optional additional cohort) of healthy Japanese participants (Part A2) and one cohort (plus one optional additional cohort) of healthy Chinese participants (Part A3). Cohort 3 of Part A1 will be extended to evaluate the effect of food intake on the PK of AZD3974. In Part A (all cohorts), participants will receive a single dose of AZD3974 or placebo.

Part B (Multiple Ascending Dose - MAD): This study part will consist of four cohorts (plus two optional additional cohorts) of healthy participants (Part B1) and one cohort (plus one optional additional cohort) of healthy Japanese participants (Part B2). In all Part B cohorts, participants will receive multiple doses of AZD3974 or placebo.

Both Part A and Part B will comprise of:

  • A Screening Period of maximum 28 days
  • A Dosing session during which participants will receive the study intervention at study specific time points.
  • Follow-up Period of 7 days post last-dose.

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 at the Screening Visit.
  • All females must have a negative pregnancy test. Females of non-childbearing potential must be confirmed via post-menopausal status or documentation of irreversible surgical sterilization at the Screening Visit.
  • Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
  • Have a body mass index between 18 and 32 kg/m2 inclusive and weigh at least 50 kg at Screening.
  • For healthy Japanese cohorts (Part A2 and Part B2): healthy male and female participants are to be Japanese (eg, natives of Japan or Japan Americans), defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
  • For healthy Chinese cohort (Part A3): healthy male and female Chinese participants for whom both parents and 4 grandparents are Chinese. This includes second and third generation participants of Chinese descent whose parents or grandparents are living in a country other than China.

Exclusion criteria

  • History of any clinically important disease or disorder which, 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.
  • Any abnormal laboratory values, vital signs, or any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
  • Any positive result on Screening for serum hepatitis B and C viruses and human immunodeficiency virus.
  • Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead electrocardiography at Screening and/or admission to the Clinical Unit .
  • Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
  • Positive screen for drugs of abuse, or alcohol, or cotinine.
  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
  • Participants who have previously received AZD3974.

Treatment and study plan

AZD3974

Drug

AZD3974 will be administered as an oral solution.

Placebo

Other

Placebo will be administered as an oral solution.

Primary outcomes

  1. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Part A: Upto Day 7; Part A1 Cohort 3: Upto Day 10; Part B: Upto Day 14

    To assess the safety and tolerability of AZD3974 following oral administration of single and multiple ascending doses in healthy participants, including Chinese and Japanese participants

Secondary outcomes

  1. Part A and Part B: Plasma concentrations of AZD3974

    Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9

    To characterize the plasma concentrations of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.

  2. Part A1-Cohort 3: Plasma concentrations of AZD3974

    Time frame: Day 1 to Day 4

    To assess the impact of food (fed) on the single-dose plasma concentrations of AZD3974

  3. Part A and Part B: Urine concentrations of AZD3974

    Time frame: Part A: Day 1; Part B: Day 1 and Day 7

    To characterize the urine concentration of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.

  4. Part A1-Cohort 3: Urine concentrations of AZD3974

    Time frame: Day 1 and Day 3

    To assess the impact of food (fed) on the single-dose urine concentrations of AZD3974

  5. Part A and Part B: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

    Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9

    To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants

  6. Part A1-Cohort 3: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

    Time frame: Day 1 to Day 4

    To assess the impact of food (fed) on the single-dose PK of AZD3974

  7. Part A: Area under concentration-time curve from time 0 to infinity (AUCinf)

    Time frame: Day 1 to Day 2

    To characterize the PK of AZD3974 following single ascending doses in healthy participants, including Chinese and Japanese participants

  8. Part A1-Cohort 3: Area under concentration-time curve from time 0 to infinity (AUCinf)

    Time frame: Day 1 to Day 4

    To assess the impact of food (fed) on the single-dose PK of AZD3974

  9. Part A and Part B: Maximum observed drug concentration (Cmax)

    Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9

    To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants

  10. Part A1-Cohort 3: Maximum observed drug concentration (Cmax)

    Time frame: Day 1 to Day 4

    To assess the impact of food (fed) on the single-dose PK of AZD3974

  11. Part A and Part B: Time to reach maximum observed concentration (tmax)

    Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9

    To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants

  12. Part A1-Cohort 3: Time to reach maximum observed concentration (tmax)

    Time frame: Day 1 to Day 4

    To assess the impact of food (fed) on the single-dose PK of AZD3974

  13. Part A and Part B: Terminal elimination half-life (t½λz)

    Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9

    To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants

  14. Part A1-Cohort 3: Terminal elimination half-life (t½λz)

    Time frame: Day 1 to Day 4

    To assess the impact of food (fed) on the single-dose PK of AZD3974

  15. Part A and Part B: Apparent total body clearance (CL/F)

    Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9

    To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants

  16. Part A1-Cohort 3: Apparent total body clearance (CL/F)

    Time frame: Day 1 to Day 4

    To assess the impact of food (fed) on the single-dose PK of AZD3974

  17. Part A and Part B: Apparent volume of distribution based on the terminal phase (Vz/F)

    Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9

    To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants

  18. Part A1-Cohort 3: Apparent volume of distribution based on the terminal phase (Vz/F)

    Time frame: Day 1 to Day 4

    To assess the impact of food (fed) on the single-dose PK of AZD3974

  19. Part A and Part B: Individual and cumulative amount of unchanged drug excreted into urine from time t0 to time tlast [Ae(0-last)]

    Time frame: Part A: Day 1; Part B: Day 1 and Day 7

    To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants

  20. Part A1-Cohort 3: Individual and cumulative amount of unchanged drug excreted into urine from time t0 to time tlast [Ae(0-last)]

    Time frame: Day 1 and Day 3

    To assess the impact of food (fed) on the single-dose PK of AZD3974

  21. Part A and Part B: Individual and cumulative percentage of dose excreted unchanged in urine from time t0 to tlast [fe(0-last)]

    Time frame: Part A: Day 1; Part B: Day 1 and Day 7

    To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants

  22. Part A1-Cohort 3: Individual and cumulative percentage of dose excreted unchanged in urine from time t0 to tlast [fe(0-last)]

    Time frame: Day 1 and Day 3

    To assess the impact of food (fed) on the single-dose PK of AZD3974

  23. Part A and Part B: Renal clearance (CLR)

    Time frame: Part A: Day 1; Part B: Day 1 and Day 7

    To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants

  24. Part A1-Cohort 3: Renal clearance (CLR)

    Time frame: Day 1 and Day 3

    To assess the impact of food (fed) on the single-dose PK of AZD3974

  25. Part A and Part B: Mean Residence Time (MRT)

    Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9

    To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.

  26. Part A1-Cohort 3: Mean Residence Time (MRT)

    Time frame: Day 1 to Day 4

    To assess the impact of food (fed) on the single-dose PK of AZD3974

  27. Part A and Part B: Time delay between drug administration and the first observed concentration (tlag)

    Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9

    To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.

  28. Part A1-Cohort 3: Time delay between drug administration and the first observed concentration (tlag)

    Time frame: Day 1 to Day 4

    To assess the impact of food (fed) on the single-dose PK of AZD3974

  29. Part A and Part B: Time of last quantifiable concentration (tlast)

    Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9

    To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.

  30. Part A1-Cohort 3: Time of last quantifiable concentration (tlast)

    Time frame: Day 1 to Day 4

    To assess the impact of food (fed) on the single-dose PK of AZD3974

  31. Part A and Part B: Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1 t2)]

    Time frame: Part A: Day 1; Part B: Day 1 and Day 7

    To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.

  32. Part A1-Cohort 3: Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1 t2)]

    Time frame: Day 1 and Day 3

    To assess the impact of food (fed) on the single-dose PK of AZD3974

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

    Time frame: Part A: Day 1; Part B: Day 1 and Day 7

    To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.

  34. Part A1-Cohort 3: 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 3

    To assess the impact of food (fed) on the single-dose PK of AZD3974

  35. Part A and Part B: Cumulative amount of unchanged drug excreted into urine (Aeinf)

    Time frame: Part A: Day 1; Part B : Day 1 and Day 7

    To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.

  36. Part A1-Cohort 3: Cumulative amount of unchanged drug excreted into urine (Aeinf)

    Time frame: Day 1 and Day 3

    To assess the impact of food (fed) on the single-dose PK of AZD3974

  37. Part B: Area under concentration time curve in the dosing interval (AUCtau)

    Time frame: Day 1 to Day 9

    To characterize the PK of AZD3974 following multiple ascending doses in healthy participants, including Japanese participants

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

    Time frame: Day 1 to Day 9

    To characterize the PK of AZD3974 following multiple ascending doses in healthy participants, including Japanese participants.

  39. Part B: Accumulation ratio for AUC calculated as steady State AUCτ/First Dose AUCτ (Rac AUC)

    Time frame: Day 1 to Day 9

    To characterize the PK of AZD3974 following multiple ascending doses in healthy participants, including Japanese participants

  40. Part B: Accumulation ratio for Cmax calculated as steady State Cmax/First Dose Cmax (Rac Cmax)

    Time frame: Day 1 to Day 9

    To characterize the PK of AZD3974 following multiple ascending doses in healthy participants, including Japanese participants.

  41. Part B: Temporal change parameter calculated as steady State AUCτ/First Dose AUCinf (TCP)

    Time frame: Day 1 to Day 9

    To characterize the PK of AZD3974 following multiple ascending doses in healthy participants, including Japanese participants.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Parexel

Registry information

Official study title

A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD3974 After Single and Multiple Ascending Dosing to Healthy Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2025
Registry last updated
Jul 1, 2026

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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