NCT06857695

A Study to Assess the Mass Balance and ADME of [14C]AZD5004 and the Absolute Bioavailability of AZD5004

An Open-Label Study to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD5004 and Absolute Bioavailability of AZD5004 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

This study in healthy volunteers aims to answer these questions: * Does the test medicine cause any important side effects? * What are the blood levels of the test medicine and how quickly does the body get rid of it? * How much of the test medicine taken by mouth gets into the bloodstream? * How does the body break down and get rid of the test medicine? This study will take place at one site in Nottingham, United Kingdom, and plans to enrol 8 healthy men aged 30-65 years, who will be involved in both parts of the study.

Detailed description

In this 2-part study, healthy volunteers will be given three doses of test medicine to find out how the body breaks down and gets rid of the test medicine. Two doses will be 'radiolabelled' - they will contain a small amount of radioactivity (Carbon-14) so that it can be tracked in the body. The amount of radiactivity is less than 6 days of the average radiation exposure received in the UK each year, and slightly less than the radiation dose that would result from a single head x-ray or two leg x-rays. This study in healthy volunteers aims to answer these questions: * Does the test medicine cause any important side effects? * What are the blood levels of the test medicine and how quickly does the body get rid of it? * How much of the test medicine taken by mouth gets into the bloodstream? * How does the body break down and get rid of the test medicine? This study will take place at one site in Nottingham, United Kingdom. It plans to enrol 8 healthy men aged 30-65 years, who will be involved in both parts of the study. In Part 1, volunteers will receive a single dose of the test medicine by mouth and, on the same day, a very tiny dose of radiolabelled study medicine by injection into a vein. After a minimum of 7 days, in Part 2, volunteers will receive a dose of test medicine containing a very tiny amount of radio label, by mouth. They'll stay in the clinic for up to 6 nights in Part 1 and 8 nights in Part 2 and take up to 7 weeks to finish the study. We'll collect blood and urine samples to do safety tests. Over a period of at least 15 days, we'll take many blood samples. In Part 2 volunteers will collect all their urine and faeces so that we can measure the amount of test medicine and its breakdown products.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD5004 film-coated tablet	oral, fasted
DRUG	[14C]AZD5004 Solution for Infusion	intravenous, fasted
DRUG	[14C]AZD5004 Oral Solution	oral, fasted

Timeline

• Start date: 2025-03-06
• Primary completion: 2025-05-05
• Completion: 2025-05-05
• First posted: 2025-03-04
• Last updated: 2025-05-28

Locations

1 site across 1 country: United Kingdom