Phase I mass balance and ADME study of [14C]AZD5462 (QSC302264)
Research type
Research Study
Full 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
IRAS ID
1010747
Contact name
Sofia Moreno
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, AZD5462, as a potential treatment for heart failure. Heart failure is where the heart is unable to pump blood around the body properly, usually because it is too weak or stiff. It is a long-term condition that gets gradually worse over time, and can occur at any age but is most common in older people. Common symptoms are breathlessness, fatigue, swollen ankles and legs, feeling lightheaded and fainting.
In this study, we’ll give healthy volunteers single doses of test medicine to find out how the body breaks down and gets rid of the test medicine. The test medicine will be ‘radiolabelled’ - it will contain a small amount of radioactivity (Carbon-14) so that we can track it in the body.
In this study in healthy volunteers, we aim 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 gets into the bloodstream?
* How does the body break down and get rid of the test medicine?This study will take place at 1 site in Nottingham.
We plan to enrol 8 healthy men aged 30-65 years.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 tablets by mouth and shortly afterwards, a tiny dose of radiolabelled test medicine by injection into a vein. There will be a minimum 7-day period between dosing in each period. They’ll stay in the clinic throughout both study periods for a single residency of 12 nights, and take approximately 6 weeks to finish the study.
We’ll collect blood and urine samples to do safety tests. Over a period of approximately 12 days, we’ll take many blood samples and volunteers will collect all their urine (Periods 1 and 2) and faeces (Period 1) so that we can measure the amount of test medicine and its breakdown products.
REC name
London - Brent Research Ethics Committee
REC reference
25/LO/0124
Date of REC Opinion
12 May 2025
REC opinion
Further Information Favourable Opinion