NCT06989983

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	AZD5462 film-coated tablet	Oral, fasted
DRUG	[14C]AZD5462 Solution for Infusion	Intravenous, fasted
DRUG	[14C]AZD5462 Oral Solution	Oral, fasted

Timeline

• Start date: 2025-05-20
• Primary completion: 2025-06-25
• Completion: 2025-06-25
• First posted: 2025-05-25
• Last updated: 2025-07-04

Locations

1 site across 1 country: United Kingdom