Study identifier:D7260C00010
ClinicalTrials.gov identifier:NCT06857695
EudraCT identifier:N/A
CTIS identifier:N/A
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
Healthy Participants
Phase 1
Yes
AZD5004 film-coated tablet, [14C]AZD5004 Solution for Infusion, [14C]AZD5004 Oral Solution
Male
8
Interventional
30 Years - 65 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Mar 2025 by AstraZeneca
AstraZeneca
Quotient Sciences Limited
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.
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.
Location
Status
Location
Ruddington, United Kingdom, NG11 6JS
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Experimental: AZD5004 A single dose of AZD5004 film-coated tablet and a single dose of [14C]AZD5004 Solution for Infusion (Part 1) A single dose of [14C]AZD5004 Oral Solution (Part 2) | - |
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