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

NCT06989983 | Completed Phase 1

• 1 other identifier: D9090C00009
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Heart failure

Outcome Measures

Primary Outcomes (5)

• Amount of AZD5462 excreted (Ae) - Period 1

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

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

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

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

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

• Cumulative amount of AZD5462 excreted (CumAe) - Period 1

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

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

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

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

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

• Absolute bioavailability - Period 2

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

  Plasma sample collection from pre-dose to 72 hours post-dose

Secondary Outcomes (29)

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

  Plasma sample collection from pre-dose to 168 hours post-dose

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

  Plasma sample collection from pre-dose to 168 hours post-dose

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

  Plasma sample collection from pre-dose to 168 hours post-dose

• 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

  Plasma sample collection from pre-dose to 168 hours post-dose

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

  Plasma sample collection from pre-dose to 168 hours post-dose

Study Arms (1)

AZD5462

EXPERIMENTAL

In Period 1, participants will receive one oral dose of \[14C\]AZD5462. In Period 2, participants will receive one oral dose of AZD5462 and one intravenous dose of \[14C\]AZD5462.

Drug: AZD5462 film-coated tablet; Drug: [14C]AZD5462 Solution for Infusion; Drug: [14C]AZD5462 Oral Solution

Interventions

AZD5462 film-coated tablet DRUG

Oral, fasted

Also known as: AZD5462

AZD5462

[14C]AZD5462 Solution for Infusion DRUG

Intravenous, fasted

Also known as: AZD5462

AZD5462

[14C]AZD5462 Oral Solution DRUG

Oral, fasted

Also known as: AZD5462

AZD5462

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Quotient Sciences: collaborator

Study Sites (1)

Research Site

Ruddington, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Philip Evans, MBChB, MRCS (Ed)

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 25, 2025
• Study Start: May 20, 2025
• Primary Completion: June 25, 2025
• Study Completion: June 25, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

GB (1)