Phase 1 ADME and Absolute Bioavailability study of [14C]AZD5004 (QSC302514)
Research type
Research Study
Full title
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.
IRAS ID
1011013
Contact name
Vidya Narayanaswami
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, AZD5004, as a potential treatment for Type 2 Diabetes, a common condition that causes the level of sugar (glucose) in the blood to become too high. It may also be used to help with chronic weight management in adults who are obese or overweight.
This will be a 2-part study, where we’ll give healthy volunteers 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 we can track it in the body. The amount of radioactivity is slightly less than 6 days of the average annual radiation exposure received in the UK, or the radiation dose that would result from two x-rays to the chest.
We will 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 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 1 site in Nottingham.
We plan 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 radiolabel, 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.
REC name
North East - York Research Ethics Committee
REC reference
25/NE/0002
Date of REC Opinion
11 Feb 2025
REC opinion
Further Information Favourable Opinion