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Completed

NCT Number: NCT06989983

A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD5462 and the Absolute Bioavailability of AZD5462

A study to investigate how the body breaks down and gets rid of the test medicine, AZD5462.

To help investigate this, the test medicine is radiolabelled, which means that the test medicine has a radioactive component (carbon-14), which helps us to track where the test medicine is in the body. The safety and tolerability of the test medicine will also be studied.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Ruddington, NG11 6JS, United Kingdom

About this study

This is an open-label, two-period study designed to assess the mass balance recovery, absorption, metabolism, excretion of [14C]AZD5462 and the absolute bioavailability of AZD5462 in healthy male participants.

The study will take place at 1 site in Nottingham, and enrol 8 healthy men aged 30-65 years. The study will include 2 Periods:

  • In Period 1 volunteers will receive a single dose of radiolabelled test medicine as a liquid by mouth.
  • In Period 2 volunteers will receive a single dose of the test medicine as capsules by mouth and shortly afterwards, a very tiny dose of radiolabelled study medicine by injection into a vein.

The participants will be resident in the clinical unit throughout both study periods for a total of 12 nights. The total study duration is approximately up to 6 weeks.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy males aged 30 to 65 years inclusive
  • BMI in the range 18.0 - 32.0 kg/m2 inclusive and body weight ≥ 50 kg and ≤ 100 kg
  • Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)

Exclusion criteria

  • History of any clinically significant disease or disorder
  • History or presence of clinically significant gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
  • History of active malignancy within 2 years, or under investigation for any form of cancer
  • Participants who do not have suitable veins for multiple venepunctures/cannulation
  • Clinically significant abnormal clinical chemistry, haematology or urinalysis
  • Any clinically significant abnormalities in vital signs
  • Any clinically significant abnormalities on 12-lead ECG
  • Abnormal renal function
  • Radiation exposure exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years, occupationally exposed worker, or have been administered IMP in a radiolabelled ADME study in the last 12 months.
  • Use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins and minerals
  • Current smokers or known or suspected history of alcohol or drug abuse
  • Excessive intake of caffeine-containing drinks or food

Treatment and study plan

AZD5462 film-coated tablet

Drug

Oral, fasted

Other names: AZD5462

[14C]AZD5462 Solution for Infusion

Drug

Intravenous, fasted

Other names: AZD5462

[14C]AZD5462 Oral Solution

Drug

Oral, fasted

Other names: AZD5462

Primary outcomes

  1. Amount of AZD5462 excreted (Ae) - Period 1

    Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose

    Mass balance recovery of total radioactivity of [14C]AZD5462 in urine and faecal samples

  2. Amount of AZD5462 excreted expressed as a percentage of the dose administered (Fe) - Period 1

    Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose

    Mass balance recovery of total radioactivity of [14C]AZD5462 in urine and faecal samples

  3. Cumulative amount of AZD5462 excreted (CumAe) - Period 1

    Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose

    Mass balance recovery of total radioactivity of [14C]AZD5462 in urine and faecal samples

  4. Cumulative amount of AZD5462 excreted expressed as a percentage of the dose administered (CumFe) - Period 1

    Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose

    Mass balance recovery of total radioactivity of [14C]AZD5462 in urine and faecal samples

  5. Absolute bioavailability - Period 2

    Time frame: Plasma sample collection from pre-dose to 72 hours post-dose

    Absolute bioavailability (F) based on AUC0-inf of oral and IV administration, adjusted for dose

Secondary outcomes

  1. Time of maximum observed concentration (tmax) for AZD5462 and total radioactivity - Period 1

    Time frame: Plasma sample collection from pre-dose to 168 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  2. Maximum observed concentration (Cmax) for AZD5462 and total radioactivity - Period 1

    Time frame: Plasma sample collection from pre-dose to 168 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  3. Area under the curve from time 0 to the time of last measurable concentration (AUC0-t) for AZD5462 and total radioactivity - Period 1

    Time frame: Plasma sample collection from pre-dose to 168 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  4. Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUC0-extrap) for AZD5462 and total radioactivity - Period 1

    Time frame: Plasma sample collection from pre-dose to 168 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  5. Terminal elimination half-life (t1/2) for AZD5462 and total radioactivity - Period 1

    Time frame: Plasma sample collection from pre-dose to 168 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  6. First order rate constant associated with the terminal (log-linear) portion of the curve (λz) for AZD5462 and total radioactivity - Period 1

    Time frame: Plasma sample collection from pre-dose to 168 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  7. Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) for AZD5462 and total radioactivity - Period 1

    Time frame: Plasma sample collection from pre-dose to 168 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  8. Renal clearance calculated using plasma AUC (CLR) for AZD5462 and total radioactivity - Period 1

    Time frame: Plasma sample collection from pre-dose to 168 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma and urine

  9. Apparent volume of distribution based on the terminal phase calculated using AUC(0 inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) for AZD5462 and total radioactivity - Period 1

    Time frame: Plasma sample collection from pre-dose to 168 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma and urine

  10. Area under the curve (AUC) of circulating plasma total radioactivity (TR) or accounting for 10% or more of the dose in excreta - Period 1

    Time frame: Plasma, urine and faecal samples from pre-dose until 168 hours post-dose

    Identification of the chemical structure of each metabolite accounting for more than 10% by AUC of circulating TR or accounting for 10% or more of the dose in urine and faeces

  11. Blood:plasma concentration ratios - Period 1

    Time frame: Whole blood samples and plasma samples collected from pre-dose until 168 hours post-dose

    Blood:plasma concentration ratios of total radioactivity

  12. Amount of unchanged AZD5462 excreted in urine (Ae) - Period 2

    Time frame: Urine sample collection from pre-dose to 72 hours post-dose

    Recovery of total radioactivity of [14C]AZD5462 in urine

  13. Amount of unchanged AZD5462 excreted in urine expressed as a percentage of the radioactive dose administered (Fe) - Period 2

    Time frame: Urine sample collection from pre-dose to 72 hours post-dose

    Recovery of total radioactivity of [14C]AZD5462 in urine

  14. Cumulative amount of unchanged AZD5462 excreted in urine (CumAe) - Period 2

    Time frame: Urine sample collection from pre-dose to 72 hours post-dose

    Recovery of total radioactivity of [14C]AZD5462 in urine

  15. Cumulative amount of unchanged AZD5462 excreted in urine expressed as a percentage of the radioactive dose administered (CumFe) - Period 2

    Time frame: Urine sample collection from pre-dose to 72 hours post-dose

    Recovery of total radioactivity of [14C]AZD5462 in urine

  16. Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD5462 and total radioactivity - Period 1

    Time frame: Plasma sample collection from pre-dose to 168 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  17. Time of maximum observed concentration (tmax) for AZD5462 and [14C]AZD5462 - Period 2

    Time frame: Plasma sample collection from pre-dose to 72 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  18. Maximum observed concentration (Cmax) for AZD5462 and [14C]AZD5462 - Period 2

    Time frame: Plasma sample collection from pre-dose to 72 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  19. Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD5462 and [14C]AZD5462 - Period 2

    Time frame: Plasma sample collection from pre-dose to 72 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  20. Area under the curve from time 0 to the time of last measurable concentration (AUC0-t) for AZD5462 and [14C]AZD5462 - Period 2

    Time frame: Plasma sample collection from pre-dose to 72 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  21. Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUC0-extrap) for AZD5462 and [14C]AZD5462- Period 2

    Time frame: Plasma sample collection from pre-dose to 72 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  22. Terminal elimination half-life (t1/2) for AZD5462 and [14C]AZD5462 - Period 2

    Time frame: Plasma sample collection from pre-dose to 72 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  23. First order rate constant associated with the terminal (log-linear) portion of the curve (λz) for AZD5462 and [14C]AZD5462 - Period 2

    Time frame: Plasma sample collection from pre-dose to 72 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  24. Total body clearance calculated after a single IV administration (CL) for AZD5462 and [14C]AZD5462 - Period 2

    Time frame: Plasma sample collection from pre-dose to 72 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  25. Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) for AZD5462 and [14C]AZD5462 - Period 2

    Time frame: Plasma sample collection from pre-dose to 72 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  26. Volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single IV administration (Vz) for AZD5462 and [14C]AZD5462 - Period 2

    Time frame: Plasma sample collection from pre-dose to 72 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  27. Apparent volume of distribution at steady state after a single IV administration (Vss) for AZD5462 and [14C]AZD5462 - Period 2

    Time frame: Plasma sample collection from pre-dose to 72 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  28. Apparent volume of distribution based on the terminal phase calculated using AUC(0 inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) for AZD5462 and [14C]AZD5462 - Period 2

    Time frame: Plasma sample collection from pre-dose to 72 hours post-dose

    PK of AZD5462 and [14C]AZD5462 in plasma

  29. Number of subjects with treatment-related adverse events - Periods 1 and 2

    Time frame: Through study duration, an average of 7 weeks

    To provide additional safety and tolerability information for AZD5462

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Quotient Sciences

Registry information

Official study title

An Open-Label, Two-Period Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD5462 and the Absolute Bioavailability of AZD5462 in Healthy Male Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 25, 2025
Registry last updated
Jul 4, 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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