Phase I Mass balance and ADME study of [14C]AZD4604 (QSC300487)
Research type
Research Study
Full title
An Open-Label, Two-Part, Sequential Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4604 and the Absolute Bioavailability of AZD4604 in Healthy Male and Female Subjects
IRAS ID
1008292
Contact name
Oliwia Buraczewska
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, AZD4604, as a potential treatment for asthma. Asthma is a common lung condition caused by inflammation (swelling) of the breathing tubes that carry air in and out of the lungs, causing occasional breathing difficulties such as wheezing, shortness of breath, chest tightness and cough.
In this study we’ll give healthy volunteers three single doses of the test medicine to find out how the body breaks down and gets rid of it. Two doses of 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 one non-NHS site in Nottingham.
We plan to enrol 8 healthy men and women aged 18-65 years who will be involved in both parts of the study.In Part 1, volunteers will receive a dose of test medicine containing a very tiny amount of radiolabel, by injection into a vein, shortly followed by a single inhaled dose of the test medicine. In Part 2, volunteers will receive a dose of test medicine also containing a very tiny amount of radiolabel, by mouth. In both parts volunteers will stay in the clinic for 15 nights, there will be a minimum 21-day gap between each study part, and it will take up to 13 weeks to finish the study. A follow-up phone call will be conducted 6 to 10 days after discharge from Part 2.
We’ll collect blood and urine samples to do safety tests. Over a period of at least 15 days for each part, we’ll take many blood samples and volunteers will collect all their urine and faeces so that we can measure the amount of test medicine and its breakdown products.
REC name
HSC REC B
REC reference
23/NI/0150
Date of REC Opinion
19 Jan 2024
REC opinion
Further Information Favourable Opinion