NCT06157255

An ADME Study of [14C]AZD4604 and the Absolute Bioavailability of AZD4604

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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. This study in healthy volunteers will explore the following 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, and plans to enrol 8 healthy men and women aged 18-65 years who will be involved in both parts of the study.

Detailed description

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, healthy volunteers will be given single doses of test medicine to find out how the body breaks down and gets rid of the test medicine. Two doses of the test medicine will be 'radiolabelled' - they will contain a small amount of radioactivity (Carbon-14) - so that it can be tracked in the body. This study in healthy volunteers will explore the following 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. It plans 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 radio label, 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 containing a very tiny amount of radio label, by mouth. In both parts volunteers will stay in the clinic for 15 nights, there will be a minimum 21 day washout period 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. Blood and urine samples will be collected to do safety tests. Over a period of at least 15 days for each part, many blood samples will be taken and volunteers will collect all their urine and faeces so that the amount of test medicine and its breakdown products can be measured.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	AZD4604 Inhalation Powder, 1 mg	3 mg dose, inhaled, fasted
DRUG	[14C]AZD4604 Solution for Infusion 6 μg/mL (NMT 37.0 kBq/5 mL)	30 μg, intravenous, fasted
DRUG	[14C]AZD4604 Oral Solution, 4 mg (NMT 37.0 kBq)	4 mg, oral, fasted

Timeline

• Start date: 2024-02-16
• Primary completion: 2024-05-20
• Completion: 2024-05-20
• First posted: 2023-12-05
• Last updated: 2024-05-29

Locations

1 site across 1 country: United Kingdom